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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 K012068
Device Name WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
Applicant
Sims Portex , Ltd.
Hythe
Hythe, Kent,  GB CT 21 6JL
Applicant Contact CLAIRE MULLINS
Correspondent
Sims Portex , Ltd.
Hythe
Hythe, Kent,  GB CT 21 6JL
Correspondent Contact CLAIRE MULLINS
Regulation Number884.6100
Classification Product Code
MQE  
Date Received07/02/2001
Decision Date 08/03/2001
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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