AESCULAP NOVOSYN ABSORBABLE 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 Aesculap Novosyn Absorbable Suture.

Pre-market Notification Details

Device IDK122734
510k NumberK122734
Device Name:AESCULAP NOVOSYN ABSORBABLE 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 Received2012-09-06
Decision Date2012-12-18
Summary:summary

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