The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Vivosorb Sheet, Model Fs01.
| Device ID | K042811 |
| 510k Number | K042811 |
| Device Name: | VIVOSORB SHEET, MODEL FS01 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Polyganics BV L.J. ZIELSTRAWEG 1 Groningen, NL 9713-gx |
| Contact | Jan Nieuwenhuis |
| Correspondent | Jan Nieuwenhuis Polyganics BV L.J. ZIELSTRAWEG 1 Groningen, NL 9713-gx |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2004-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717703990324 | K042811 | 000 |
| 08717703990218 | K042811 | 000 |
| 08717703990201 | K042811 | 000 |
| 08717703990195 | K042811 | 000 |