SKIL-CARE SUPER-SOFT LIMB RESTRAINTS

Restraint, Protective

SKIL-CARE CORP.

The following data is part of a premarket notification filed by Skil-care Corp. with the FDA for Skil-care Super-soft Limb Restraints.

Pre-market Notification Details

Device IDK792012
510k NumberK792012
Device Name:SKIL-CARE SUPER-SOFT LIMB RESTRAINTS
ClassificationRestraint, Protective
Applicant SKIL-CARE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMQ  
CFR Regulation Number880.6760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-10-05
Decision Date1979-10-26

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