FDA 510(k) Application Details - K012220

Device Classification Name	Catheter, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K012220
Device Name	Catheter, Assisted Reproduction
Applicant	TTJ BIOMEDICAL, LLC. 2885 AURORA AVENUE, SUITE 15 BOULDER, CO 80303 US Other 510(k) Applications for this Company
Contact	RICHARD JORTBERG 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	07/16/2001
Decision Date	08/27/2001
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