K920100 is an FDA 510(k) clearance for the GSU HANDPIECE ADAPTER. This device is classified as a Apparatus, Electrosurgical (Class II - Special Controls, product code HAM).
Submitted by Beacon Laboratories, Inc. (Broomfield, US). The FDA issued a Cleared decision on February 3, 1992, 25 days after receiving the submission on January 9, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K920100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1992 |
| Decision Date | February 03, 1992 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HAM — Apparatus, Electrosurgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |