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 |