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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 K000628
Device Name WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
Applicant
Sims Portex , Ltd.
Hythe
Hythe, Kent,  GB CT 21 6JL
Applicant Contact GILES BISHOP
Correspondent
Sims Portex , Ltd.
Hythe
Hythe, Kent,  GB CT 21 6JL
Correspondent Contact GILES BISHOP
Regulation Number884.6100
Classification Product Code
MQE  
Date Received02/24/2000
Decision Date 03/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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