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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Disposable
510(k) Number K890924
Device Name THERMO-PACK
Applicant
Medical Manufacturers, Inc.
750 W. Belleview Ave. #301
Englewood,  CO  80110
Applicant Contact SCOTT NICHOLS
Correspondent
Medical Manufacturers, Inc.
750 W. Belleview Ave. #301
Englewood,  CO  80110
Correspondent Contact SCOTT NICHOLS
Regulation Number890.5710
Classification Product Code
IMD  
Date Received02/24/1989
Decision Date 03/14/1989
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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