SYNTHETIC ABSORBABLE SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

JOHNSON & JOHNSON INTERNATIONAL

The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Synthetic Absorbable Suture.

Pre-market Notification Details

Device IDK944937
510k NumberK944937
Device Name:SYNTHETIC ABSORBABLE SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant JOHNSON & JOHNSON INTERNATIONAL 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactSally L Maher
CorrespondentSally L Maher
JOHNSON & JOHNSON INTERNATIONAL 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-06
Decision Date1995-05-19

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