FDA 510(k) Application Details - K033904

Device Classification Name	Microtools, Assisted Reproduction (Pipettes)   More FDA Info for this Device
510(K) Number	K033904
Device Name	Microtools, Assisted Reproduction (Pipettes)
Applicant	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. SPENCER, IN 47460 US Other 510(k) Applications for this Company
Contact	BRENDA DAVIS 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	12/17/2003
Decision Date	01/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review