The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for The Bioplate Resorbable Endobrow Fixation System.
| Device ID | K051845 |
| 510k Number | K051845 |
| Device Name: | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 -4310 |
| Contact | Jesus T Farinas |
| Correspondent | Jesus T Farinas BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 -4310 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-07 |
| Decision Date | 2005-07-27 |
| Summary: | summary |