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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Hot/Cold Water
510(k) Number K791176
Device Name 3M COLD/HOT WATER BAG AND WRAP
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number880.6085
Classification Product Code
FPF  
Date Received06/25/1979
Decision Date 07/30/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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