MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Modified Coated Vicryl* Rapide (polyglactin 910) Suture.

Pre-market Notification Details

Device IDK033746
510k NumberK033746
Device Name:MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant ETHICON, INC. ROUTE 22 WEST Somerville,  NJ  08876
ContactRey Librojo
CorrespondentRey Librojo
ETHICON, INC. ROUTE 22 WEST Somerville,  NJ  08876
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-01
Decision Date2003-12-18
Summary:summary

NIH GUDID Devices

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