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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 K895860
Device Name MEDI-PACK
Applicant
Heatmax Mfg., Inc.
Venture Management Consulting
131 Grand View Ter.
Brooklyn,  CT  06234
Applicant Contact GENE ZAMBA
Correspondent
Heatmax Mfg., Inc.
Venture Management Consulting
131 Grand View Ter.
Brooklyn,  CT  06234
Correspondent Contact GENE ZAMBA
Regulation Number890.5710
Classification Product Code
IMD  
Date Received10/03/1989
Decision Date 01/02/1990
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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