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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 K894926
Device Name STAT-PAD
Applicant
Hettel Accessories, Inc.
3881 W. 6th St.
Los Angeles,  CA  90020
Applicant Contact BERND HETTEL
Correspondent
Hettel Accessories, Inc.
3881 W. 6th St.
Los Angeles,  CA  90020
Correspondent Contact BERND HETTEL
Regulation Number890.5710
Classification Product Code
IMD  
Date Received08/02/1989
Decision Date 09/05/1989
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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