The following data is part of a premarket notification filed by Polymedics Innovations Gmbh with the FDA for Suprasdrm Biodegradable Matrix Wound Dressing.
| Device ID | K170213 |
| 510k Number | K170213 |
| Device Name: | SupraSDRM Biodegradable Matrix Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | PolyMedics Innovations GmbH Heerweg 15D Denkendorf, DE 73770 |
| Contact | Kenneth K. Kleinhenz |
| Correspondent | Kenneth K. Kleinhenz PolyMedics Innovations GmbH Heerweg 15D Denkendorf, DE 73770 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-24 |
| Decision Date | 2017-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260184023011 | K170213 | 000 |
| 04260184023073 | K170213 | 000 |
| 04260184023097 | K170213 | 000 |
| 04260184023110 | K170213 | 000 |
| 04260184023134 | K170213 | 000 |
| 04260184023158 | K170213 | 000 |
| 04260184023226 | K170213 | 000 |
| 04260184023325 | K170213 | 000 |
| 04260184023424 | K170213 | 000 |
| 04260184023035 | K170213 | 000 |