FDA 510(k) Application Details - K101988

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K101988
Device Name	Accessory, Assisted Reproduction
Applicant	SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD 77325 JOYCE WAY ECHO, OR 97826 US Other 510(k) Applications for this Company
Contact	CHARLES MACK 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	07/14/2010
Decision Date	02/08/2011
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