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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 K151845
Device Name Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
Applicant
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact ROAIDA JOHNSON
Correspondent
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Correspondent Contact ROAIDA JOHNSON
Regulation Number890.5710
Classification Product Code
MPO  
Date Received07/07/2015
Decision Date 03/18/2016
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
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