The following data is part of a premarket notification filed by Amsco Co. with the FDA for Hall Osteon.
| Device ID | K833187 |
| 510k Number | K833187 |
| Device Name: | HALL OSTEON |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | AMSCO CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-19 |
| Decision Date | 1983-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854023218 | K833187 | 000 |
| 20845854023201 | K833187 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HALL OSTEON 74117584 1742964 Live/Registered |
CONMED CORPORATION 1990-11-23 |