The following data is part of a premarket notification filed by Future Medical Systems, Sa with the FDA for Biodhoc.
| Device ID | K024185 |
| 510k Number | K024185 |
| Device Name: | BIODHOC |
| Classification | Pin, Fixation, Smooth |
| Applicant | FUTURE MEDICAL SYSTEMS, SA 504 MCCORMICK DR. Glen Burnie, MD 21061 |
| Contact | Steve Janin |
| Correspondent | Steve Janin FUTURE MEDICAL SYSTEMS, SA 504 MCCORMICK DR. Glen Burnie, MD 21061 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-19 |
| Decision Date | 2004-01-15 |
| Summary: | summary |