Gazmatic International · 89-08 · UNITED KINGDOM
For Gazmatic International, import alert is 89-08; country is UNITED KINGDOM; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product code is 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 12/01/2011; address is Swinboard Rd , Essex, UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Gazmatic International verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- UNITED KINGDOM verified
- Address
- Swinboard Rd , Essex, UNITED KINGDOM verified
- Date published
- 12/01/2011 verified
- Product code
- 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology each item verified
- FDA notes
- Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II | Massager; Class II each item verified
What the source says
Gazmatic International Date Published : 12/01/2011 Swinboard Rd , Essex, UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
73 - - - -- Anesthesiology Date Published: 12/01/2011 Notes: Massager; Class II 74 - - - -- Cardiovascular Date Published: 12/01/2011 Notes: Massager; Class II 76 - - - -- Dental Date Published: 12/01/2011 Notes: Massager; Class II 77 - - - -- Ear,Nose And Throat Date Published: 12/01/2011 Notes: Massager; Class II 78 - - - -- Gastroenterological & Urological Date Published: 12/01/2011 Notes: Massager; Class II 79 - - - -- General & Plastic Surgery Date Published: 12/01/2011 Notes: Massager; Class II 80 - - - -- General Hospital/Personal Use Date Published: 12/01/2011 Notes: Massager; Class II 84 - - - -- Neurological Date Published: 12/01/2011 Notes: Massager; Class II 85 - - - -- Obstetrical & Gynecological Date Published: 12/01/2011 Notes: Massager; Class II 86 - - - -- Ophthalmic Date Published: 12/01/2011 Notes: Massager; Class II 87 - - - -- Orthopedic Date Published: 12/01/2011 Notes: Massager; Class II 89 - - - -- Physical Medicine Date Published: 12/01/2011 Notes: Massager; Class II 90 - - - -- Radiology Date Published: 12/01/2011 Notes: Massager; Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html