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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 Rd.
Hythe, Kent
England Ct21 6db,  GB
Applicant Contact STEVE OGILVIE
Correspondent
Portex , Ltd.
Military Rd.
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
Predetermined Change
Control Plan Authorized		 No
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