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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K120147
Device Name ACE STAPLER AND CARTRIDGE
Applicant
BAROSENSE, INC
250 CHESAPEAKE DRIVE
REDWOOD CITY,  CA  94063
Applicant Contact SHEILA STEVENS, PHD
Correspondent
BAROSENSE, INC
250 CHESAPEAKE DRIVE
REDWOOD CITY,  CA  94063
Correspondent Contact SHEILA STEVENS, PHD
Regulation Number876.1500
Classification Product Code
OCW  
Date Received01/18/2012
Decision Date 02/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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