K781486 is an FDA 510(k) clearance for the STERI-VAC POWER UNITS. This device is classified as a Evacuator, Oral Cavity (Class I - General Controls, product code EHZ).
Submitted by Cpac, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978, 30 days after receiving the submission on August 28, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K781486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1978 |
| Decision Date | September 27, 1978 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EHZ — Evacuator, Oral Cavity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |