TYPE 316L STAINLESS STEEL WIRE

Cerclage, Fixation

WINN HIRSCH & ASSOC.

The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Type 316l Stainless Steel Wire.

Pre-market Notification Details

Device IDK880309
510k NumberK880309
Device Name:TYPE 316L STAINLESS STEEL WIRE
ClassificationCerclage, Fixation
Applicant WINN HIRSCH & ASSOC. 5256 N.W. 15TH ST. Margate,  FL  33063
ContactWinn Hirsch
CorrespondentWinn Hirsch
WINN HIRSCH & ASSOC. 5256 N.W. 15TH ST. Margate,  FL  33063
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-25
Decision Date1988-02-29

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