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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 K860444
Device Name MAZING HEAT DISPOSABLE WARM PACK
Applicant
Leebryan Intl.
P.O. Box 152
Hampton,  NJ  08827
Applicant Contact PETER J FERNANDEZ
Correspondent
Leebryan Intl.
P.O. Box 152
Hampton,  NJ  08827
Correspondent Contact PETER J FERNANDEZ
Regulation Number890.5710
Classification Product Code
IMD  
Date Received02/04/1986
Decision Date 02/27/1986
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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