K854593 is an FDA 510(k) clearance for the NORFOLK MEDICAL PERITONEAL-ACCESS PORT. This device is classified as a Device, Peritoneal Access, Subcutaneous, Implanted (Class III - Premarket Approval, product code LMQ).
Submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on February 4, 1986, 78 days after receiving the submission on November 18, 1985.
This device falls under the General Hospital FDA review panel.
| 510(k) Number | K854593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1985 |
| Decision Date | February 04, 1986 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | LMQ - Device, Peritoneal Access, Subcutaneous, Implanted |
| Device Class | Class III - Premarket Approval |