The following data is part of a premarket notification filed by Polymedics Innovations Gmbh with the FDA for Suprathel Wound And Burn Dressing.
| Device ID | K090160 |
| 510k Number | K090160 |
| Device Name: | SUPRATHEL WOUND AND BURN DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | POLYMEDICS INNOVATIONS GMBH HEERWEG 15D Denkendorf, DE D-73770 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz POLYMEDICS INNOVATIONS GMBH HEERWEG 15D Denkendorf, DE D-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 | 2009-01-22 |
| Decision Date | 2009-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260184021130 | K090160 | 000 |
| 04260184021567 | K090160 | 000 |
| 04260184021475 | K090160 | 000 |
| 04260184021376 | K090160 | 000 |
| 04260184021277 | K090160 | 000 |