K896806 is an FDA 510(k) clearance for the CATHETER PLUG/PROTECTOR. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).
Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on February 26, 1990, 87 days after receiving the submission on December 1, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K896806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1989 |
| Decision Date | February 26, 1990 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNY — Accessories, Catheter, G-u |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |