The following data is part of a premarket notification filed by Augmenix , Inc. with the FDA for Markit Tissue Marker-1ml Markit Tissue Marker-3ml Markit Tissue Marker-10ml.
| Device ID | K121964 |
| 510k Number | K121964 |
| Device Name: | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML |
| Classification | Marker, Radiographic, Implantable |
| Applicant | AUGMENIX , INC. 204 SECOND AVENUE LOWER LEVEL Waltham, MA 02451 |
| Contact | Eric Ankerud |
| Correspondent | Eric Ankerud AUGMENIX , INC. 204 SECOND AVENUE LOWER LEVEL Waltham, MA 02451 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-05 |
| Decision Date | 2013-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864661000119 | K121964 | 000 |