SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100


Device Classification Name

endoscope channel accessory

510(k) Number K080764
Device Name SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
Applicant
MAX ENDOSCOPY INC.
1410 highland road, suite 6
macedonia, 
OH 
44056

Applicant Contact richard m wolf
Correspondent
MAX ENDOSCOPY INC.
1410 highland road, suite 6
macedonia, 
OH 
44056

Correspodent Contact richard m wolf
Regulation Number 876.1500
Classification Product Code
ODC  
Date Received 03/18/2008
Decision Date 05/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No