The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Norfolk Medical Norport Family Of Ports.
Device ID | K102385 |
510k Number | K102385 |
Device Name: | NORFOLK MEDICAL NORPORT FAMILY OF PORTS |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | NORFOLK MEDICAL PRODUCTS, INC. 7350 NORTH RIDGEWAY Skokie, IL 60076 |
Contact | Michael J Dalton |
Correspondent | Michael J Dalton NORFOLK MEDICAL PRODUCTS, INC. 7350 NORTH RIDGEWAY Skokie, IL 60076 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-23 |
Decision Date | 2011-01-14 |
Summary: | summary |