K801328 is an FDA 510(k) clearance for the THE EQUALIZER. This device is classified as a Instrument, Manual, Surgical, General Use (Class I - General Controls, product code MDM).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980, 6 days after receiving the submission on June 3, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K801328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1980 |
| Decision Date | June 09, 1980 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MDM — Instrument, Manual, Surgical, General Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |