K955339 is an FDA 510(k) clearance for the HYDROLOGY 5000. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on March 13, 1996, 114 days after receiving the submission on November 20, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K955339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1995 |
| Decision Date | March 13, 1996 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |