K133604 is an FDA 510(k) clearance for the ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 10, 2014, 46 days after receiving the submission on November 25, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K133604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2013 |
| Decision Date | January 10, 2014 |
| Days to Decision | 46 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBC — Motor, Drill, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4360 |