The following data is part of a premarket notification filed by Fraser Harlake, Inc. with the FDA for Fraser Harlake Dental Anti-polution Sys.
| Device ID | K833692 |
| 510k Number | K833692 |
| Device Name: | FRASER HARLAKE DENTAL ANTI-POLUTION SYS |
| Classification | Apparatus, Gas-scavenging |
| Applicant | FRASER HARLAKE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-18 |
| Decision Date | 1983-11-29 |