FDA 510(k) Application Details - K041435

Device Classification Name	Microtools, Assisted Reproduction (Pipettes)   More FDA Info for this Device
510(K) Number	K041435
Device Name	Microtools, Assisted Reproduction (Pipettes)
Applicant	MID-ATLANTIC DIAGNOSTICS, INC. 438 NORTH ELMWOOD RD. MARLTON, NJ 08053 US Other 510(k) Applications for this Company
Contact	SUSAN J BUSH 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	05/28/2004
Decision Date	09/29/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review