PEDIATRIC LIMB HOLDER

Restraint, Protective

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Pediatric Limb Holder.

Pre-market Notification Details

Device IDK963466
510k NumberK963466
Device Name:PEDIATRIC LIMB HOLDER
ClassificationRestraint, Protective
Applicant DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
ContactCamille Matlock
CorrespondentCamille Matlock
DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
Product CodeFMQ  
CFR Regulation Number880.6760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-03
Decision Date1997-02-13
Summary:summary

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