FDA 510(k) Application Details - K001967

Device Classification Name Media, Reproductive

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510(K) Number K001967
Device Name Media, Reproductive
Applicant INVITROCARE, INC.
11408 SORRENTO VALLEY RD.
SUITE 202
SAN DIEGO, CA 92121 US
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Contact ROBERT E LOVINS
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Regulation Number 884.6180

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Classification Product Code MQL
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Date Received 06/28/2000
Decision Date 08/14/2000
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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