VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V


Device Classification Name

hysteroscope (and accessories)

510(k) Number K022445
Device Name VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
Original Applicant
OLYMPUS OPTICAL CO., LTD.
two corporate center dr.
melville, 
NY 
11747 -3157

Original Contact laura storms-tyler
Regulation Number 884.1690
Classification Product Code
HIH  
Date Received 07/25/2002
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No