The following data is part of a premarket notification filed by Norfolk Medical with the FDA for Norport Ct-pc, Lucent Non-coring Needel Infusion Set.
| Device ID | K111101 |
| 510k Number | K111101 |
| Device Name: | NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | NORFOLK MEDICAL 7350 N. RIDGEWAY Skokie, IL 60076 |
| Contact | Michael J Dalton |
| Correspondent | Michael J Dalton NORFOLK MEDICAL 7350 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 | 2011-04-20 |
| Decision Date | 2011-08-25 |
| Summary: | summary |