The following data is part of a premarket notification filed by Cpac, Inc. with the FDA for Steri-vac Power Units.
| Device ID | K781486 |
| 510k Number | K781486 |
| Device Name: | STERI-VAC POWER UNITS |
| Classification | Evacuator, Oral Cavity |
| Applicant | CPAC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHZ |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-28 |
| Decision Date | 1978-09-27 |