AESCULAP ENDOSCOPIC CLIP SYTEM

Clip, Implantable

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Endoscopic Clip Sytem.

Pre-market Notification Details

Device IDK080753
510k NumberK080753
Device Name:AESCULAP ENDOSCOPIC CLIP SYTEM
ClassificationClip, Implantable
Applicant AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactLisa M Boyle
CorrespondentLisa M Boyle
AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeFZP  
Subsequent Product CodeDSS
Subsequent Product CodeGDO
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-17
Decision Date2008-04-02
Summary:summary

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