PEDICRAFT INFANT REFLUX WEDGE

Holder, Infant Position

PEDICRAFT, INC.

The following data is part of a premarket notification filed by Pedicraft, Inc. with the FDA for Pedicraft Infant Reflux Wedge.

Pre-market Notification Details

Device IDK905629
510k NumberK905629
Device Name:PEDICRAFT INFANT REFLUX WEDGE
ClassificationHolder, Infant Position
Applicant PEDICRAFT, INC. 2014 PERRY PLACE Jacksonville,  FL  32207
ContactEric Nord
CorrespondentEric Nord
PEDICRAFT, INC. 2014 PERRY PLACE Jacksonville,  FL  32207
Product CodeFRP  
CFR Regulation Number880.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-14
Decision Date1991-03-13

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