The following data is part of a premarket notification filed by Orphan Medical, Inc. with the FDA for Repliderm Wound Dressing.
| Device ID | K963228 |
| 510k Number | K963228 |
| Device Name: | REPLIDERM WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | ORPHAN MEDICAL, INC. 13911 RIDGEDALE DR., SUITE 475 Minnetonka, MN 55305 |
| Contact | Dayton T Reardan |
| Correspondent | Dayton T Reardan ORPHAN MEDICAL, INC. 13911 RIDGEDALE DR., SUITE 475 Minnetonka, MN 55305 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-19 |
| Decision Date | 1996-12-18 |
| Summary: | summary |