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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infant Heel Warmer (Chemical Heat Pack)
510(k) Number K964523
Device Name RECOVER INFANT HEEL WARMER (5100)
Applicant
FLORIDA MEDICAL INDUSTRIES, INC.
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Applicant Contact PATRICK J LAMB
Correspondent
FLORIDA MEDICAL INDUSTRIES, INC.
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Correspondent Contact PATRICK J LAMB
Regulation Number890.5710
Classification Product Code
MPO  
Date Received11/12/1996
Decision Date 02/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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