FDA 510(k) Application Details - K011327

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K011327
Device Name	Accessory, Assisted Reproduction
Applicant	ZANDER MEDICAL SUPPLIES, INC. 755 8TH CT., SUITE #4 P.O.650790 VERO BEACH, FL 32962 US Other 510(k) Applications for this Company
Contact	FRED ZANDER 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	05/01/2001
Decision Date	08/15/2002
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