Sambo Ventec Corp · 89-08 · KOREA (THE REPUBLIC OF)
For Sambo Ventec Corp, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 is Hyperbaric Oxygen Chamber | Hyperbaric Oxygen Chamber; product code is 73 C - - BF Chamber, Hyperbaric | 79 K - - PJ Chamber, Oxygen, Topical, Extremity; date published is 02/25/2013; address is 535-2 Dong Pae Ri Gyo Ha Myen , Paju City Kyung Gi Do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Sambo Ventec Corp 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 535-2 Dong Pae Ri Gyo Ha Myen , Paju City Kyung Gi Do, KOREA (THE REPUBLIC OF) verified
- Date published
- 02/25/2013 verified
- Product code
- 73 C - - BF Chamber, Hyperbaric | 79 K - - PJ Chamber, Oxygen, Topical, Extremity each item verified
- Product
- Hyperbaric Oxygen Chamber | Hyperbaric Oxygen Chamber each item verified
- FDA notes
- class II | Class II each item verified
What the source says
Sambo Ventec Corp Date Published : 02/25/2013 535-2 Dong Pae Ri Gyo Ha Myen , Paju City Kyung Gi Do, KOREA (THE REPUBLIC OF)
— 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, Product and FDA notes
73 C - - BF Chamber, Hyperbaric Date Published: 02/25/2013 Desc: Hyperbaric Oxygen Chamber Notes: class II 79 K - - PJ Chamber, Oxygen, Topical, Extremity Date Published: 02/25/2013 Desc: Hyperbaric Oxygen Chamber Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html