SURGICAL INSTRUMENTS KIT

Wrap, Sterilization

CLINICAL RESOURCES, INC.

The following data is part of a premarket notification filed by Clinical Resources, Inc. with the FDA for Surgical Instruments Kit.

Pre-market Notification Details

Device IDK941466
510k NumberK941466
Device Name:SURGICAL INSTRUMENTS KIT
ClassificationWrap, Sterilization
Applicant CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin,  IL  60123
ContactDavid Insco
CorrespondentDavid Insco
CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin,  IL  60123
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-28
Decision Date1994-04-22

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