The following data is part of a premarket notification filed by Biovision Gmbh with the FDA for Leadfix Bioresorbable Membrance Pin System.
| Device ID | K974392 |
| 510k Number | K974392 |
| Device Name: | LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | BIOVISION GMBH 2320 FARADAY AVE. Carlsbad, CA 92008 -7216 |
| Contact | Foster Boop |
| Correspondent | Foster Boop BIOVISION GMBH 2320 FARADAY AVE. Carlsbad, CA 92008 -7216 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-21 |
| Decision Date | 1998-01-30 |
| Summary: | summary |