FDA 510(k) Application Details - K991271

Device Classification Name Needle, Assisted Reproduction

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510(K) Number K991271
Device Name Needle, Assisted Reproduction
Applicant CASMED UK
39 NORK WAY BANSTEAD
SURREY SM7 1PB GB
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Contact DEBORAH CASTLE
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Regulation Number 884.6100

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Classification Product Code MQE
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Date Received 04/13/1999
Decision Date 03/08/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K991271


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