CRYOTOP


Device Classification Name

labware, assisted reproduction

510(k) Number K112695
Device Name CRYOTOP
Applicant
KITAZATO BIOPHARMA CO;LTD
611 west 5th st
austin, 
TX 
78701

Applicant Contact richard vincins cqa,rac(us,eu)
Correspondent
KITAZATO BIOPHARMA CO;LTD
611 west 5th st
austin, 
TX 
78701

Correspodent Contact richard vincins cqa,rac(us,eu)
Regulation Number 884.6160
Classification Product Code
MQK  
Date Received 09/15/2011
Decision Date 12/12/2012
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