K032572 is an FDA 510(k) clearance for the A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT. This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on December 3, 2003, 105 days after receiving the submission on August 20, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K032572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2003 |
| Decision Date | December 03, 2003 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBW — Controller, Foot, Handpiece And Cord |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |