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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Infant Position
510(k) Number K905629
Device Name PEDICRAFT INFANT REFLUX WEDGE
Applicant
PEDICRAFT, INC.
2014 PERRY PLACE
JACKSONVILLE,  FL  32207
Applicant Contact ERIC NORD
Correspondent
PEDICRAFT, INC.
2014 PERRY PLACE
JACKSONVILLE,  FL  32207
Correspondent Contact ERIC NORD
Regulation Number880.5680
Classification Product Code
FRP  
Date Received12/14/1990
Decision Date 03/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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