TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

SUTURES INDIA PVT., LTD.

The following data is part of a premarket notification filed by Sutures India Pvt., Ltd. with the FDA for Trusynth, Absorbable (polyglactin 910) Suture.

Pre-market Notification Details

Device IDK081003
510k NumberK081003
Device Name:TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SUTURES INDIA PVT., LTD. 472 D, 13TH CROSS, 4TH PHASE PEENYA INDUSTRIAL AREA Bangalore,  IN 560058
ContactL.g. Chandrasekhar
CorrespondentL.g. Chandrasekhar
SUTURES INDIA PVT., LTD. 472 D, 13TH CROSS, 4TH PHASE PEENYA INDUSTRIAL AREA Bangalore,  IN 560058
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-08
Decision Date2008-06-09

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