The following data is part of a premarket notification filed by Lares Manufacturing Co., Inc. with the FDA for Lares Air Pressure Gauge.
| Device ID | K801534 |
| 510k Number | K801534 |
| Device Name: | LARES AIR PRESSURE GAUGE |
| Classification | Unit, Operative Dental |
| Applicant | LARES MANUFACTURING CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-03 |
| Decision Date | 1980-07-14 |