DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A


Device Classification Name

endoscope and/or accessories

510(k) Number K021179
Device Name DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
Original Applicant
OLYMPUS OPTICAL CO., LTD.
two corporate center dr.
melville, 
NY 
11747 -3157

Original Contact laura storms-tyler
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 04/15/2002
Decision Date 07/05/2002
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