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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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More FDA Info for this Product Code
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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