STAINLESS STEEL SOFT SUTURE WIRE

Wire, Surgical

BREGMA INTERNATIONAL TRADING COMPANY LTD.

The following data is part of a premarket notification filed by Bregma International Trading Company Ltd. with the FDA for Stainless Steel Soft Suture Wire.

Pre-market Notification Details

Device IDK990355
510k NumberK990355
Device Name:STAINLESS STEEL SOFT SUTURE WIRE
ClassificationWire, Surgical
Applicant BREGMA INTERNATIONAL TRADING COMPANY LTD. 214-111 RESEARCH DR. Saskatoon, Saskatchewan,  CA S7n 3r2
ContactAssem Hedayat
CorrespondentAssem Hedayat
BREGMA INTERNATIONAL TRADING COMPANY LTD. 214-111 RESEARCH DR. Saskatoon, Saskatchewan,  CA S7n 3r2
Product CodeLRN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-05
Decision Date1999-07-08

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