The following data is part of a premarket notification filed by Scion Medical Technologies Llc with the FDA for General And Plastic Surgery.
| Device ID | K140835 |
| 510k Number | K140835 |
| Device Name: | GENERAL AND PLASTIC SURGERY |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SCION MEDICAL TECHNOLOGIES LLC 90 Oak St Newton, MA 02464 |
| Contact | Chris Lewis |
| Correspondent | Chris Lewis SCION MEDICAL TECHNOLOGIES LLC 90 Oak St Newton, MA 02464 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-02 |
| Decision Date | 2014-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866479000107 | K140835 | 000 |