K863723 is an FDA 510(k) clearance for the NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on October 29, 1986, 36 days after receiving the submission on September 23, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K863723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1986 |
| Decision Date | October 29, 1986 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |