ACE STAPLER AND CARTRIDGE


Device Classification Name

endoscopic tissue approximation device

510(k) Number K110829
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

Correspodent Contact sheila stevens, phd
Regulation Number 876.1500
Classification Product Code
OCW  
Date Received 03/24/2011
Decision Date 06/03/2011
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