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FDA 510(k) Application Details - K990847
Device Classification Name
Microtools, Assisted Reproduction (Pipettes)
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510(K) Number
K990847
Device Name
Microtools, Assisted Reproduction (Pipettes)
Applicant
HUMAGEN FERTILITY DIAGNOSTICS, INC.
2400 HUNTER'S WAY
CHARLOTTESVILLE, VA 22911 US
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Contact
CINDY SHOWALTER
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Regulation Number
884.6130
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Classification Product Code
MQH
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More FDA Info for this Product Code
Date Received
03/15/1999
Decision Date
07/14/1999
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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