FDA 510(k) Application Details - K003734

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K003734
Device Name	Media, Reproductive
Applicant	SAGE BIOPHARMA 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GRACE HOLLAND 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	12/04/2000
Decision Date	12/21/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review