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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 K991271
Device Name OOCYTE ASPIRATION NEEDLE
Applicant
Casmed UK
39 Nork Way Banstead
Surrey,  GB SM7 1PB
Applicant Contact DEBORAH CASTLE
Correspondent
Casmed UK
39 Nork Way Banstead
Surrey,  GB SM7 1PB
Correspondent Contact DEBORAH CASTLE
Regulation Number884.6100
Classification Product Code
MQE  
Date Received04/13/1999
Decision Date 03/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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