The following data is part of a premarket notification filed by Superdimension Inc. with the FDA for Superdimension Marker Delivery Kit.
| Device ID | K110093 |
| 510k Number | K110093 |
| Device Name: | SUPERDIMENSION MARKER DELIVERY KIT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SUPERDIMENSION INC. 161 CHESHIRE LANE NORTH SUITE 100 Minneapolis, MN 55441 |
| Contact | Jonathan Kovach |
| Correspondent | Jonathan Kovach SUPERDIMENSION INC. 161 CHESHIRE LANE NORTH SUITE 100 Minneapolis, MN 55441 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-12 |
| Decision Date | 2011-02-11 |
| Summary: | summary |