The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Brigham Tibial Cement Pressurizer.
| Device ID | K833675 |
| 510k Number | K833675 |
| Device Name: | BRIGHAM TIBIAL CEMENT PRESSURIZER |
| Classification | Dispenser, Cement |
| Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIH |
| CFR Regulation Number | 888.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-18 |
| Decision Date | 1983-12-12 |