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FDA 510(k) Application Details - K150748
Device Classification Name
Microtools, Assisted Reproduction (Pipettes)
More FDA Info for this Device
510(K) Number
K150748
Device Name
Microtools, Assisted Reproduction (Pipettes)
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 US
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Contact
NAOMI FUNKHOUSER
Other 510(k) Applications for this Contact
Regulation Number
884.6130
More FDA Info for this Regulation Number
Classification Product Code
MQH
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More FDA Info for this Product Code
Date Received
03/23/2015
Decision Date
12/18/2015
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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