The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Controlled Delivery For Osteoplasty (cdo System) And Graft Preparation System.
| Device ID | K072330 |
| 510k Number | K072330 |
| Device Name: | CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM |
| Classification | Syringe, Piston |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Paula Deming |
| Correspondent | Paula Deming BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-20 |
| Decision Date | 2007-12-06 |
| Summary: | summary |