FDA 510(k) Application Details - K062524

Device Classification Name	System, Assisted Reproduction Laser   More FDA Info for this Device
510(K) Number	K062524
Device Name	System, Assisted Reproduction Laser
Applicant	MINITUBE OF AMERICA, INC 419 VENTURE COURT VERONA, WI 53593 US Other 510(k) Applications for this Company
Contact	FREDERICK KIKKERS Other 510(k) Applications for this Contact
Regulation Number	884.6200   More FDA Info for this Regulation Number
Classification Product Code	MRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2006
Decision Date	12/15/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review