K913135 is an FDA 510(k) clearance for the LM-300TWIN. This device is classified as a Light, Surgical, Endoscopic (Class II - Special Controls, product code FSW).
Submitted by Leisegang Medical, Inc. (Boca Raton, US). The FDA issued a Cleared decision on September 18, 1991, 64 days after receiving the submission on July 16, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K913135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1991 |
| Decision Date | September 18, 1991 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FSW — Light, Surgical, Endoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |