The following data is part of a premarket notification filed by Renaissance Pharmaceutical, Inc. with the FDA for Wound Hydrogel And/or Sterile Wound Hydrogel.
| Device ID | K954384 |
| 510k Number | K954384 |
| Device Name: | WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | RENAISSANCE PHARMACEUTICAL, INC. PO BOX 216 2115 THE BACK ROAD Glenbrook, NV 89413 |
| Contact | Darlene Taylor-mccord |
| Correspondent | Darlene Taylor-mccord RENAISSANCE PHARMACEUTICAL, INC. PO BOX 216 2115 THE BACK ROAD Glenbrook, NV 89413 |
| 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 | 1995-09-19 |
| Decision Date | 1995-10-16 |