The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Gtr Biodegradable Membrane System.
| Device ID | K033074 |
| 510k Number | K033074 |
| Device Name: | INION GTR BIODEGRADABLE MEMBRANE SYSTEM |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224TCK20139 | K033074 | 000 |
| M224TCK20119 | K033074 | 000 |
| M224TCK20029 | K033074 | 000 |
| M224MBR20009 | K033074 | 000 |
| 06438408010750 | K033074 | 000 |
| 06438408007279 | K033074 | 000 |
| 06438408005572 | K033074 | 000 |
| 06438408005565 | K033074 | 000 |