The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Norfolk Medical Peritoneal-access Port.
| Device ID | K854593 |
| 510k Number | K854593 |
| Device Name: | NORFOLK MEDICAL PERITONEAL-ACCESS PORT |
| Classification | Device, Peritoneal Access, Subcutaneous, Implanted |
| 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 | LMQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-18 |
| Decision Date | 1986-02-04 |