The following data is part of a premarket notification filed by Izun Pharmaceuticals Corporation with the FDA for Periopatch.
| Device ID | K103054 |
| 510k Number | K103054 |
| Device Name: | PERIOPATCH |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | IZUN PHARMACEUTICALS CORPORATION 420 LEXINGTON AVENUE New York, NY 10170 |
| Contact | Irving Wiesen |
| Correspondent | Irving Wiesen IZUN PHARMACEUTICALS CORPORATION 420 LEXINGTON AVENUE New York, NY 10170 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-15 |
| Decision Date | 2011-02-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PERIOPATCH 76535278 3393782 Live/Registered |
IZUN PHARMACEUTICALS CORPORATION 2003-08-07 |