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 |