FDA 510(k) Application Details - K980061

Device Classification Name	Cannula, Intrauterine Insemination   More FDA Info for this Device
510(K) Number	K980061
Device Name	Cannula, Intrauterine Insemination
Applicant	ROCKET MEDICAL PLC 1151 HOPE ST. STAMFORD, CT 06907 US Other 510(k) Applications for this Company
Contact	R KEEN Other 510(k) Applications for this Contact
Regulation Number	884.5250   More FDA Info for this Regulation Number
Classification Product Code	MFD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/1998
Decision Date	03/02/1998
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