Monosyn Quick Synthetic Absorbable Surgical Suture

Suture, Absorbable, Synthetic, Polyglycolic Acid

Aesculap, Inc.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Monosyn Quick Synthetic Absorbable Surgical Suture.

Pre-market Notification Details

Device IDK171001
510k NumberK171001
Device Name:Monosyn Quick Synthetic Absorbable Surgical Suture
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactKathy A. Racosky
CorrespondentKathy A. Racosky
Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-04
Decision Date2017-10-23
Summary:summary

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