AESCULAP MONOMAX ABSORBABLE SUTURE

Suture, Recombinant Technology

AESCULAP, INC.

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

Pre-market Notification Details

Device IDK100876
510k NumberK100876
Device Name:AESCULAP MONOMAX ABSORBABLE SUTURE
ClassificationSuture, Recombinant Technology
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 CodeNWJ  
CFR Regulation Number878.4494 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-30
Decision Date2010-07-14
Summary:summary

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