K864920 is an FDA 510(k) clearance for the SCANLAN (TM) INSTRUMENT TRAY. This device is classified as a Tray, Surgical, Instrument (Class I - General Controls, product code FSM).
Submitted by Scanlan Intl., Inc. (Saint Paul, US). The FDA issued a Cleared decision on January 12, 1987, 27 days after receiving the submission on December 16, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K864920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1986 |
| Decision Date | January 12, 1987 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FSM — Tray, Surgical, Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |