Automatic Mfg. Ltd. · 89-08 · HONG KONG SAR
For Automatic Mfg. Ltd., import alert is 89-08; country is HONG KONG SAR; 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 09/16/2009; address is 5/F. , 227 Wai Yip Street , Kwun Tong, Kowloon HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- Automatic Mfg. Ltd. 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
- HONG KONG SAR verified
- Address
- 5/F. , 227 Wai Yip Street , Kwun Tong, Kowloon HONG KONG SAR verified
- Date published
- 09/16/2009 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
- All devices. GPI = DE. Shealy Relaxmate Glasses. 5/6/1994. verified
What the source says
Automatic Mfg. Ltd. Date Published : 09/16/2009 5/F. , 227 Wai Yip Street , Kwun Tong, Kowloon HONG KONG SAR
— 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: 09/16/2009 Notes: All devices. GPI = DE. Shealy Relaxmate Glasses. 5/6/1994. 74 - - - -- Cardiovascular Date Published: 09/16/2009 76 - - - -- Dental Date Published: 09/16/2009 77 - - - -- Ear,Nose And Throat Date Published: 09/16/2009 78 - - - -- Gastroenterological & Urological Date Published: 09/16/2009 79 - - - -- General & Plastic Surgery Date Published: 09/16/2009 80 - - - -- General Hospital/Personal Use Date Published: 09/16/2009 84 - - - -- Neurological Date Published: 09/16/2009 85 - - - -- Obstetrical & Gynecological Date Published: 09/16/2009 86 - - - -- Ophthalmic Date Published: 09/16/2009 87 - - - -- Orthopedic Date Published: 09/16/2009 89 - - - -- Physical Medicine Date Published: 09/16/2009 90 - - - -- Radiology Date Published: 09/16/2009
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html