FDA 510(k) Application Details - DEN150008

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150008
Device Name	INVOcell
Applicant	INVO BIOSCIENCE 407 R MYSTIC AVENUE MEDFORD, MA 02155-6335 US Other 510(k) Applications for this Company
Contact	Kathleen Karloff Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2015
Decision Date	11/02/2015
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review