FDA 510(k) Application Details - K083081

Device Classification Name	Implanted Subcutaneous Securement Catheter   More FDA Info for this Device
510(K) Number	K083081
Device Name	Implanted Subcutaneous Securement Catheter
Applicant	INTERRAD MEDICAL, INC. 18555 37TH AVE N PLYMOUTH, MN 55446 US Other 510(k) Applications for this Company
Contact	Sew-Wah Tay Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	OKC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2008
Decision Date	03/04/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review