The following data is part of a premarket notification filed by Superdimension Inc. with the FDA for Superdimension Nitinol/gold Fiducial Marker.
| Device ID | K120796 |
| 510k Number | K120796 |
| Device Name: | SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SUPERDIMENSION INC. 161 CHESHIRE LANE SUITE 100 Plymouth, MN 55441 |
| Contact | Karyl Haskell |
| Correspondent | Karyl Haskell SUPERDIMENSION INC. 161 CHESHIRE LANE SUITE 100 Plymouth, MN 55441 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-15 |
| Decision Date | 2012-10-26 |
| Summary: | summary |