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 |