K941164 is an FDA 510(k) clearance for the TAP EXPRESS EJECTOR. This device is classified as a Evacuator, Oral Cavity (Class I - General Controls, product code EHZ).
Submitted by Tap Express, Inc. (Miami, US). The FDA issued a Cleared decision on May 18, 1994, 68 days after receiving the submission on March 11, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K941164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1994 |
| Decision Date | May 18, 1994 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EHZ — Evacuator, Oral Cavity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |