FDA 510(k) Application Details - K021890

Device Classification Name Media, Reproductive

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510(K) Number K021890
Device Name Media, Reproductive
Applicant VITROLIFE SWEDEN AB
1800 MASSACHUSETTS AVENUE NW
WASHINGTON, DC 20036-1800 US
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Contact GARY L YINGLING
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Regulation Number 884.6180

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Classification Product Code MQL
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Date Received 06/10/2002
Decision Date 09/06/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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