K871192 is an FDA 510(k) clearance for the SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY 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 June 10, 1987, 78 days after receiving the submission on March 24, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K871192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1987 |
| Decision Date | June 10, 1987 |
| Days to Decision | 78 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 |