The following data is part of a premarket notification filed by Laminaire Corp. with the FDA for Dental Office Environment Control Unit.
| Device ID | K780701 |
| 510k Number | K780701 |
| Device Name: | DENTAL OFFICE ENVIRONMENT CONTROL UNIT |
| Classification | Evacuator, Oral Cavity |
| Applicant | LAMINAIRE CORP. 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 | 1978-04-26 |
| Decision Date | 1978-05-16 |