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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact STEVE OGILVIE
Regulation Number884.6110
Classification Product Code
MQF  
Date Received09/29/2003
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
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