FDA 510(k) Application Details - K991380

Device Classification Name Media, Reproductive

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510(K) Number K991380
Device Name Media, Reproductive
Applicant ADVANCED REPRODUCTIVE TECHNOLOGIES
3722 AVENUE SAUSALITO
IRVINE, CA 92606 US
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Contact GREG HOLLAND
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Regulation Number 884.6180

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Classification Product Code MQL
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Date Received 04/21/1999
Decision Date 04/19/2000
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



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