The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Norfolk Medical-sportport-family Of Ports.
Device ID | K112713 |
510k Number | K112713 |
Device Name: | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | NORFOLK MEDICAL PRODUCTS, INC. 7350 NORTH RIDGEWAY Skokie, IL 60076 |
Contact | Michael Dalton |
Correspondent | Michael Dalton NORFOLK MEDICAL PRODUCTS, INC. 7350 NORTH RIDGEWAY Skokie, IL 60076 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-19 |
Decision Date | 2011-10-27 |
Summary: | summary |