FDA 510(k) Application Details - K143498

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K143498
Device Name	Media, Reproductive
Applicant	LifeGlobal Group, LLC 393 Soundview Road Guilford, CT 06437 US Other 510(k) Applications for this Company
Contact	MICHAEL D CECCHI Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2014
Decision Date	01/20/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review