PEDIATRIC POSITION HOLDER

Holder, Infant Position

KAYE PRODUCTS, INC.

The following data is part of a premarket notification filed by Kaye Products, Inc. with the FDA for Pediatric Position Holder.

Pre-market Notification Details

Device IDK810609
510k NumberK810609
Device Name:PEDIATRIC POSITION HOLDER
ClassificationHolder, Infant Position
Applicant KAYE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFRP  
CFR Regulation Number880.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-06
Decision Date1981-03-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.