FDA 510(k) Application Details - K000618

Device Classification Name Media, Reproductive

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510(K) Number K000618
Device Name Media, Reproductive
Applicant VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
1900 K STREET, N.W.
WASHINGTON, DC 20006-1108 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 02/17/2000
Decision Date 05/17/2000
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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