CUTALON NYLON POLYAMIDE SURGICAL SUTURE

Suture, Nonabsorbable, Synthetic, Polyamide

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for Cutalon Nylon Polyamide Surgical Suture.

Pre-market Notification Details

Device IDK981322
510k NumberK981322
Device Name:CUTALON NYLON POLYAMIDE SURGICAL SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
Applicant GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River,  MA  02720 -4740
ContactJim Kenney
CorrespondentJim Kenney
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River,  MA  02720 -4740
Product CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-10
Decision Date1998-07-07
Summary:summary

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