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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 K103549
Device Name DENOVO TEDDY GEL INFANT HEEL WARMER
Applicant
Denovo Products, LLC
17051 Alico Commerce Ct.
Unit 3
Fort Myers,  FL  33967
Applicant Contact DALE WALTERS
Correspondent
Denovo Products, LLC
17051 Alico Commerce Ct.
Unit 3
Fort Myers,  FL  33967
Correspondent Contact DALE WALTERS
Regulation Number890.5710
Classification Product Code
MPO  
Date Received12/03/2010
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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