SOVEREIGN MINI

Laparoscope, General & Plastic Surgery

AESCULAP, INC.

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

Pre-market Notification Details

Device IDK123102
510k NumberK123102
Device Name:SOVEREIGN MINI
ClassificationLaparoscope, General & Plastic Surgery
Applicant AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactDenise Adams
CorrespondentDenise Adams
AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-02
Decision Date2013-01-03
Summary:summary

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