FDA 510(k) Application Details - K063048

Device Classification Name	Tunneled Catheter Remover   More FDA Info for this Device
510(K) Number	K063048
Device Name	Tunneled Catheter Remover
Applicant	TRAN PA-C, INC. 3348 HERRINGRIDGE DR. ORLANDO, FL 32812 US Other 510(k) Applications for this Company
Contact	TOM TRAN Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	ODY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2006
Decision Date	09/14/2007
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