The following data is part of a premarket notification filed by Halifax Biomedical, Inc. with the FDA for Halifax Biomedical Tanatlum Bead Set.
| Device ID | K103417 |
| 510k Number | K103417 |
| Device Name: | HALIFAX BIOMEDICAL TANATLUM BEAD SET |
| Classification | Marker, Radiographic, Implantable |
| Applicant | HALIFAX BIOMEDICAL, INC. 3 ELIZABETH PLACE Lake Hopatcong, NJ 07849 |
| Contact | Robert A Poggie, Phd |
| Correspondent | Robert A Poggie, Phd HALIFAX BIOMEDICAL, INC. 3 ELIZABETH PLACE Lake Hopatcong, NJ 07849 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-06-28 |
| Summary: | summary |