STAINLESS STEEL SUTURE

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

SURGIMETRICS INTERNATIONAL, LTD.

The following data is part of a premarket notification filed by Surgimetrics International, Ltd. with the FDA for Stainless Steel Suture.

Pre-market Notification Details

Device IDK931915
510k NumberK931915
Device Name:STAINLESS STEEL SUTURE
ClassificationSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant SURGIMETRICS INTERNATIONAL, LTD. 4233 THAMESGATE CLOSE Norcross,  GA  30092
ContactRon Laporte
CorrespondentRon Laporte
SURGIMETRICS INTERNATIONAL, LTD. 4233 THAMESGATE CLOSE Norcross,  GA  30092
Product CodeGAQ  
CFR Regulation Number878.4495 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-16
Decision Date1994-03-03

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