The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Preloaded Tissue Marker Device.
| Device ID | K100994 |
| 510k Number | K100994 |
| Device Name: | PRELOADED TISSUE MARKER DEVICE |
| Classification | Marker, Radiographic, Implantable |
| Applicant | CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Tina M Wittchow |
| Correspondent | Tina M Wittchow CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-09 |
| Decision Date | 2010-04-30 |
| Summary: | summary |