The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Norfolk Omega Port-lp Subcutaneously Implanted.
| Device ID | K942784 |
| 510k Number | K942784 |
| Device Name: | NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | NORFOLK MEDICAL PRODUCTS, INC. 7307 N. RIDGEWAY Skokie, IL 60076 |
| Contact | Diane Field |
| Correspondent | Diane Field 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 | 1994-06-14 |
| Decision Date | 1995-05-02 |