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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 K082044
Device Name ACE STAPLER, MODEL F0031
Applicant
Barosense, Inc.
3698-C Haven Ave.
Redwood City,  CA  94063
Applicant Contact DANIEL J BALBIERZ
Correspondent
Barosense, Inc.
3698-C Haven Ave.
Redwood City,  CA  94063
Correspondent Contact DANIEL J BALBIERZ
Regulation Number876.1500
Classification Product Code
OCW  
Date Received07/18/2008
Decision Date 05/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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