The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Norfolk Norport (tm) -sp (skin Parallel).
Device ID | K872838 |
510k Number | K872838 |
Device Name: | NORFOLK NORPORT (TM) -SP (SKIN PARALLEL) |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | NORFOLK MEDICAL PRODUCTS, INC. 7307 N. RIDGEWAY Skokie, IL 60076 |
Contact | Michael J Dalton |
Correspondent | Michael J Dalton NORFOLK MEDICAL PRODUCTS, INC. 7307 N. 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 | 1987-07-20 |
Decision Date | 1987-08-25 |