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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, assisted reproduction
510(k) Number K031622
Device Name WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
Applicant
PORTEX LTD.
MILITARY ROAD
HYTHE, KENT
ENGLAND CT21 6DB,  GB
Applicant Contact STEVE OGILVIE
Correspondent
PORTEX LTD.
MILITARY ROAD
HYTHE, KENT
ENGLAND CT21 6DB,  GB
Correspondent Contact STEVE OGILVIE
Regulation Number884.6100
Classification Product Code
MQE  
Date Received05/23/2003
Decision Date 06/26/2003
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
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