FDA 510(k) Application Details - K092554

Device Classification Name	Microtools, Assisted Reproduction (Pipettes)   More FDA Info for this Device
510(K) Number	K092554
Device Name	Microtools, Assisted Reproduction (Pipettes)
Applicant	SUNLIGHT MEDICAL, INC. 12443 SAN JOSE BLVD. SUITE 602 JACKSONVILLE, FL 32223 US Other 510(k) Applications for this Company
Contact	DUNSONG YANG Other 510(k) Applications for this Contact
Regulation Number	884.6130   More FDA Info for this Regulation Number
Classification Product Code	MQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2009
Decision Date	04/30/2010
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