The following data is part of a premarket notification filed by Clairol, Inc. with the FDA for Muscle Minder: Heat Wrap W/ Hot + Cold Pack.
Device ID | K852604 |
510k Number | K852604 |
Device Name: | MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK |
Classification | Pad, Heating, Powered |
Applicant | CLAIROL, INC. 345 PARK AVE. New York, NY 10154 |
Contact | Samuel M Perry |
Correspondent | Samuel M Perry CLAIROL, INC. 345 PARK AVE. New York, NY 10154 |
Product Code | IRT |
CFR Regulation Number | 890.5740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-19 |
Decision Date | 1985-08-12 |