The following data is part of a premarket notification filed by Rhealm Pharmaceuticals, Inc. with the FDA for Dermafreeze.
Device ID | K992286 |
510k Number | K992286 |
Device Name: | DERMAFREEZE |
Classification | Vapocoolant Device |
Applicant | RHEALM PHARMACEUTICALS, INC. 258 SE 6TH AVE., SUITE 12 Delray Beach, FL 33483 |
Contact | Richard Mann |
Correspondent | Richard Mann RHEALM PHARMACEUTICALS, INC. 258 SE 6TH AVE., SUITE 12 Delray Beach, FL 33483 |
Product Code | MLY |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-07 |
Decision Date | 2000-01-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DERMAFREEZE 75287805 2402318 Dead/Cancelled |
MANN, RICHARD H. 1997-05-07 |