SUTURE REMOVAL TRAYS

Wrap, Sterilization

STERILE CONCEPTS, INC.

The following data is part of a premarket notification filed by Sterile Concepts, Inc. with the FDA for Suture Removal Trays.

Pre-market Notification Details

Device IDK943090
510k NumberK943090
Device Name:SUTURE REMOVAL TRAYS
ClassificationWrap, Sterilization
Applicant STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond,  VA  23234
ContactDarren Reeves
CorrespondentDarren Reeves
STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond,  VA  23234
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-28
Decision Date1994-08-22

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