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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 K801081
Device Name DELUXE HEAT WRAP/COLD WRAP
Applicant
The Gillette Company
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Gillette Company
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5740
Classification Product Code
IRT  
Date Received05/07/1980
Decision Date 05/14/1980
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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