The following data is part of a premarket notification filed by Rye Pharmaceuticals Pty. Ltd. with the FDA for Burnaid Burn First Aid Dressing.
| Device ID | K953505 |
| 510k Number | K953505 |
| Device Name: | BURNAID BURN FIRST AID DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | RYE PHARMACEUTICALS PTY. LTD. 916 CATALPA WAY Petaluma, CA 94954 |
| Contact | John C Price |
| Correspondent | John C Price RYE PHARMACEUTICALS PTY. LTD. 916 CATALPA WAY Petaluma, CA 94954 |
| 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 | 1995-07-26 |
| Decision Date | 1996-02-09 |