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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 K163295
Device Name Infant Transport Mattress Warmer with Disc
Applicant
RAPID AID CORP.
4120 A SLADEVIEW CRESENT
MISSISSAUGA,  CA L5L 5Z3
Applicant Contact Laureta Prifti
Correspondent
Mandell Horwitz Consultants
2995 Steven Martin Dr.
Fairfax,  VA  22031
Correspondent Contact Diane Horwitz
Regulation Number890.5710
Classification Product Code
IMD  
Date Received11/22/2016
Decision Date 07/24/2017
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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