ENDOSCOPIC CLIP SYSTEM

Clip, Implantable

AESCULAP, INC.

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

Pre-market Notification Details

Device IDK102081
510k NumberK102081
Device Name:ENDOSCOPIC CLIP SYSTEM
ClassificationClip, Implantable
Applicant AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactDenise Adams
CorrespondentDenise Adams
AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-26
Decision Date2010-08-06
Summary:summary

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