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 | K961316 |
| 510k Number | K961316 |
| Device Name: | WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | RENAISSANCE PHARMACEUTICAL, INC. 33971 SELVA SUITE 100 Dana Point, CA 92629 |
| Contact | Darelene Taylor-mccord |
| Correspondent | Darelene Taylor-mccord RENAISSANCE PHARMACEUTICAL, INC. 33971 SELVA SUITE 100 Dana Point, CA 92629 |
| 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 | 1996-04-05 |
| Decision Date | 1996-07-15 |