USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE


Device Classification Name

endoscopic access overtube, gastroenterology-urology

510(k) Number K072405
Device Name USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
Applicant
USGI MEDICAL
1140 calle cordillera
san clemente, 
CA 
92673

Applicant Contact mary lou mooney
Correspondent
USGI MEDICAL
1140 calle cordillera
san clemente, 
CA 
92673

Correspodent Contact mary lou mooney
Regulation Number 876.1500
Classification Product Code
FED  
Subsequent Product Code
ODB  
Date Received 08/27/2007
Decision Date 09/13/2007
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