K920780 is an FDA 510(k) clearance for the MEDSURG INSERTION TRAY. This device is classified as a Catheter, Subclavian (Class II — Special Controls, product code LFJ).
Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on August 19, 1994, 911 days after receiving the submission on February 20, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K920780 FDA.gov |
| FDA Decision | Cleared SEKD |
| Date Received | February 20, 1992 |
| Decision Date | August 19, 1994 |
| Days to Decision | 911 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LFJ — Catheter, Subclavian |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |