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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pad, Heating, Powered
510(k) Number K852604
Device Name MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK
Applicant
Clairol, Inc.
345 Park Ave.
New York,  NY  10154
Applicant Contact SAMUEL M PERRY
Correspondent
Clairol, Inc.
345 Park Ave.
New York,  NY  10154
Correspondent Contact SAMUEL M PERRY
Regulation Number890.5740
Classification Product Code
IRT  
Date Received06/19/1985
Decision Date 08/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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