Sambo Ventec Corp · 89-08 · KOREA (THE REPUBLIC OF)
For Sambo Ventec Corp · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; 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)"; country is KOREA (THE REPUBLIC OF); 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 2026-09-16.
- 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) 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.