ACE STAPLER AND CARTRIDGE

Endoscopic Tissue Approximation Device

BAROSENSE, INC

The following data is part of a premarket notification filed by Barosense, Inc with the FDA for Ace Stapler And Cartridge.

Pre-market Notification Details

Device IDK120147
510k NumberK120147
Device Name:ACE STAPLER AND CARTRIDGE
ClassificationEndoscopic Tissue Approximation Device
Applicant BAROSENSE, INC 250 CHESAPEAKE DRIVE Redwood City,  CA  94063
ContactSheila Stevens, Phd
CorrespondentSheila Stevens, Phd
BAROSENSE, INC 250 CHESAPEAKE DRIVE Redwood City,  CA  94063
Product CodeOCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-18
Decision Date2012-02-17
Summary:summary

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