FDA 510(k) Application Details - K990348

Device Classification Name	Catheter, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K990348
Device Name	Catheter, Assisted Reproduction
Applicant	COOPERSURGICAL, INC. 15 FOREST PKWY. SHELTON, CT 06484 US Other 510(k) Applications for this Company
Contact	DEBRA A PEKAR Other 510(k) Applications for this Contact
Regulation Number	884.6110   More FDA Info for this Regulation Number
Classification Product Code	MQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/1999
Decision Date	07/26/1999
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