LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER

Restraint, Protective

SKIL-CARE CORP.

The following data is part of a premarket notification filed by Skil-care Corp. with the FDA for Limb Holders-reusable/limb Holders-disposable/quick-cuff Limb Holder.

Pre-market Notification Details

Device IDK963456
510k NumberK963456
Device Name:LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER
ClassificationRestraint, Protective
Applicant SKIL-CARE CORP. 167 SAW MILL RIVER RD. Yonkers,  NY  10701
ContactArnold Silverman
CorrespondentArnold Silverman
SKIL-CARE CORP. 167 SAW MILL RIVER RD. Yonkers,  NY  10701
Product CodeFMQ  
CFR Regulation Number880.6760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-03
Decision Date1996-10-08
Summary:summary

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