FDA 510(k) Application Details - K962230

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

  More FDA Info for this Device
510(K) Number K962230
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
P.O. BOX 4027
BETHLEHEM, PA 18018-0027 US
Other 510(k) Applications for this Company
Contact MARK S ALSBERGE
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 06/10/1996
Decision Date 12/16/1996
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