The following data is part of a premarket notification filed by Analytic Technology with the FDA for Analytic Tech. Metal Point Heater #3001.
| Device ID | K801974 |
| 510k Number | K801974 |
| Device Name: | ANALYTIC TECH. METAL POINT HEATER #3001 |
| Classification | Instrument, Hand, Calculus Removal |
| Applicant | ANALYTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELA |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-19 |
| Decision Date | 1980-11-12 |