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 Other 510(k) Applications for this Company
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 Other 510(k) Applications for this Device   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