SKIN STAPLE REMOVAL TRAYS

Suture Removal Kit

STERILE CONCEPTS, INC.

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

Pre-market Notification Details

Device IDK943046
510k NumberK943046
Device Name:SKIN STAPLE REMOVAL TRAYS
ClassificationSuture Removal Kit
Applicant STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond,  VA  23234
ContactKay Andrews
CorrespondentKay Andrews
STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond,  VA  23234
Product CodeMCZ  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-27
Decision Date1994-07-29

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