AESCULAP STERILCONTAINER S

Wrap, Sterilization

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Sterilcontainer S.

Pre-market Notification Details

Device IDK093493
510k NumberK093493
Device Name:AESCULAP STERILCONTAINER S
ClassificationWrap, Sterilization
Applicant AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactKathy Racosky
CorrespondentKathy Racosky
AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-10
Decision Date2010-07-27
Summary:summary

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