K940535 is an FDA 510(k) clearance for the AUTO LUBE SYSTEM. This device is classified as a Motor, Surgical Instrument, Ac-powered (Class I - General Controls, product code GEY).
Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on March 21, 1994, 42 days after receiving the submission on February 7, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K940535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1994 |
| Decision Date | March 21, 1994 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GEY — Motor, Surgical Instrument, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |