FDA 510(k) Application Details - K100367

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K100367
Device Name	Media, Reproductive
Applicant	ORIGIO A/S 9915 CAM, CHIRIMOLLA SAN DIEGO, CA 92131 US Other 510(k) Applications for this Company
Contact	RONALD G LEONARDI 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	02/12/2010
Decision Date	08/27/2010
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