DEFENDO Y-OPSY IRRIGATOR


Device Classification Name

endoscope channel accessory

510(k) Number K110088
Device Name DEFENDO Y-OPSY IRRIGATOR
Applicant
BYRNE MEDICAL INCORPORATED
3150 pollok drive
conroe, 
TX 
77303

Applicant Contact john willis
Correspondent
BYRNE MEDICAL INCORPORATED
3150 pollok drive
conroe, 
TX 
77303

Correspodent Contact john willis
Regulation Number 876.1500
Classification Product Code
ODC  
Date Received 01/12/2011
Decision Date 06/10/2011
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