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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 Rd.
Hyth, Kent,  GB CT21 6DB
Applicant Contact STEVE OGILVIE
Correspondent
Portex , Ltd.
Military Rd.
Hyth, 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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