FDA 510(k) Application Details - K030961

Device Classification Name Device, Fertility Diagnostic, Proceptive

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510(K) Number K030961
Device Name Device, Fertility Diagnostic, Proceptive
Applicant MICROLIFE CORP.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 000.0000

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Classification Product Code LHD
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Date Received 03/27/2003
Decision Date 09/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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