Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K112713
Device Classification Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
More FDA Info for this Device
510(K) Number
K112713
Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant
NORFOLK MEDICAL PRODUCTS, INC.
7350 NORTH RIDGEWAY
SKOKIE, IL 60076 US
Other 510(k) Applications for this Company
Contact
MICHAEL DALTON
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
09/19/2011
Decision Date
10/27/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact