COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE

Suture, Nonabsorbable, Synthetic, Polyethylene

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Cottony Ii, Silky Ii Polydek & Tevdek Ii Polyester Suture.

Pre-market Notification Details

Device IDK021019
510k NumberK021019
Device Name:COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant GENZYME CORP. 600 AIRPORT RD. Fall River,  MA  02720 -4740
ContactMary Gray
CorrespondentMary Gray
GENZYME CORP. 600 AIRPORT RD. Fall River,  MA  02720 -4740
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-29
Decision Date2002-06-18
Summary:summary

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