FDA 510(k) Application Details - K022295

Device Classification Name Media, Reproductive

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510(K) Number K022295
Device Name Media, Reproductive
Applicant VITROLIFE SWEDEN AB
MOLNDALSVAGEN 30
GOTHENBURG SE-412 63 SE
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Contact EILER ANDERSON
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Regulation Number 884.6180

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Classification Product Code MQL
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Date Received 07/16/2002
Decision Date 09/12/2002
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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