K915064 is an FDA 510(k) clearance for the DISPOSABLE CAUTERY ABRASIVE PAD, a Instrument, Surgical, Disposable (Class I — General Controls, product code KDC), submitted by American Medical Mfg., Inc. (Calabasas, US). The FDA issued a Cleared decision on March 11, 1992, 124 days after receiving the submission on November 8, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K915064 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 08, 1991 |
| Decision Date | March 11, 1992 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KDC — Instrument, Surgical, Disposable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |