K955636 is an FDA 510(k) clearance for the SENTRY DISPOSABLE DISPERSIVE ELECTRODE, a Electrode, Electrosurgical (Class II — Special Controls, product code JOS), submitted by Sentry Medical Products, Inc. (Lombard, US). The FDA issued a Cleared decision on March 27, 1996, 107 days after receiving the submission on December 11, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K955636 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 11, 1995 |
| Decision Date | March 27, 1996 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | JOS — Electrode, Electrosurgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |