FDA 510(k) Application Details - K030525

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K030525
Device Name	Accessory, Assisted Reproduction
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	884.6120   More FDA Info for this Regulation Number
Classification Product Code	MQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2003
Decision Date	08/27/2003
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