The following data is part of a premarket notification filed by Renaissance Pharmaceutical, Inc. with the FDA for Wound Hydrogel & Sterile Wound Hydrogel.
| Device ID | K961766 |
| 510k Number | K961766 |
| Device Name: | WOUND HYDROGEL & STERILE WOUND HYDROGEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | RENAISSANCE PHARMACEUTICAL, INC. P.O. BOX 216 Glenbrook, NV 89413 |
| Contact | Darlene Taylor-mccord |
| Correspondent | Darlene Taylor-mccord RENAISSANCE PHARMACEUTICAL, INC. P.O. BOX 216 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 | 1996-05-03 |
| Decision Date | 1996-07-15 |