The following data is part of a premarket notification filed by Augmenix, Inc. with the FDA for Traceit Tissue Marker - 3ml.
| Device ID | K151998 |
| 510k Number | K151998 |
| Device Name: | TraceIT Tissue Marker - 3mL |
| Classification | Marker, Radiographic, Implantable |
| Applicant | AUGMENIX, INC. 204 SECOND AVENUE, LOWER LEVEL Waltham, MA 02451 |
| Contact | Noel Rolon |
| Correspondent | Noel Rolon AUGMENIX, INC. 204 SECOND AVENUE, LOWER LEVEL Waltham, MA 02451 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-20 |
| Decision Date | 2015-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864661000133 | K151998 | 000 |