The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Champy Bone Plates & Bone Screws.
| Device ID | K855030 |
| 510k Number | K855030 |
| Device Name: | CHAMPY BONE PLATES & BONE SCREWS |
| Classification | Plate, Bone |
| Applicant | ADVANCED BIOSEARCH ASSN. 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
| Contact | Joel S Faden |
| Correspondent | Joel S Faden ADVANCED BIOSEARCH ASSN. 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-01-30 |