K915068 is an FDA 510(k) clearance for the PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER, a Light, Surgical, Accessories (Class II — Special Controls, product code FTA), submitted by American Medical Mfg., Inc. (Calabasas, US). The FDA issued a Cleared decision on February 6, 1992, 90 days after receiving the submission on November 8, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K915068 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 08, 1991 |
| Decision Date | February 06, 1992 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FTA — Light, Surgical, Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |