The following data is part of a premarket notification filed by American Bentley with the FDA for Electrosurgical Lateral Release Probe Mod Alr-100.
| Device ID | K852683 |
| 510k Number | K852683 |
| Device Name: | ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-25 |
| Decision Date | 1985-08-12 |