DISPOSABLE BENDING CANNULA PR-233Q


Device Classification Name

endoscope and/or accessories

510(k) Number K011149
Device Name DISPOSABLE BENDING CANNULA PR-233Q
Original Applicant
THE OLYMPUS OPTICAL CO.
endoscope division
two corporate center drive
melville, 
NY 
11747 -3157

Original Contact laura stoms-tyler
Regulation Number 876.1500
Classification Product Code
KOG  
Subsequent Product Code
FGE  
Date Received 04/16/2001
Decision Date 05/15/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Special
Reviewed by Third Party No

Combination Product

No