The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Md2 Personal Infusion System.
| Device ID | K896544 |
| 510k Number | K896544 |
| Device Name: | MD2 PERSONAL INFUSION SYSTEM |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-17 |
| Decision Date | 1990-05-02 |