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 |