FDA 510(k) Application Details - K952435

Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular

  More FDA Info for this Device
510(K) Number K952435
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant B. BRAUN MEDICAL, INC.
POSTFACH 110 CARL BRAUN STR 1
D-3508
MELSUNGEN DE
Other 510(k) Applications for this Company
Contact MARK S ALSBBRGE
Other 510(k) Applications for this Contact
Regulation Number 880.5965

  More FDA Info for this Regulation Number
Classification Product Code LJT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/24/1995
Decision Date 04/17/1996
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact