FDA 510(k) Application Details - K121566

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K121566
Device Name	Accessory, Assisted Reproduction
Applicant	PLANER PLC 15696 OAKSTAND ROAD POWAY, CA 92064-3389 US Other 510(k) Applications for this Company
Contact	ERIC GRUFF 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	05/29/2012
Decision Date	11/29/2012
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