KITAZATO OPU NEEDLE


Device Classification Name

needle, assisted reproduction

510(k) Number K112462
Device Name KITAZATO OPU NEEDLE
Applicant
KITAZATO MEDICAL CO., LTD.
611 west 5th street
austin, 
TX 
78701

Applicant Contact richard vincins
Correspondent
KITAZATO MEDICAL CO., LTD.
611 west 5th street
austin, 
TX 
78701

Correspodent Contact richard vincins
Regulation Number 884.6100
Classification Product Code
MQE  
Date Received 08/26/2011
Decision Date 11/26/2012
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