The following data is part of a premarket notification filed by Halifax Biomedical, Inc. with the FDA for Tantalum Bead Set, Model P003175.
| Device ID | K090581 |
| 510k Number | K090581 |
| Device Name: | TANTALUM BEAD SET, MODEL P003175 |
| Classification | Marker, Radiographic, Implantable |
| Applicant | HALIFAX BIOMEDICAL, INC. 4 INNOVATION DR. Dundas, Ontario, CA L9h 7p3 |
| Contact | Roshana Ahmed |
| Correspondent | Roshana Ahmed HALIFAX BIOMEDICAL, INC. 4 INNOVATION DR. Dundas, Ontario, CA L9h 7p3 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-03 |
| Decision Date | 2009-08-21 |
| Summary: | summary |