WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER

Device Classification Name

catheter, assisted reproduction

510(k) Number K033084
Device Name WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
Applicant
PORTEX LTD.
military road
hythe, kent, 

GB

ct21 6db

Applicant Contact steve ogilvie
Correspondent
PORTEX LTD.
military road
hythe, kent, 

GB

ct21 6db

Correspodent Contact steve ogilvie
Regulation Number 884.6110
Classification Product Code
MQF  
Date Received 09/29/2003
Decision Date 12/19/2003
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

Recalls CDRH Recalls