The following data is part of a premarket notification filed by Nuscience Consulting And Management Group, Llc with the FDA for Smartshears.
| Device ID | K112400 |
| 510k Number | K112400 |
| Device Name: | SMARTSHEARS |
| Classification | Cutter, Surgical |
| Applicant | NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC P.O. BOX 8507 Fleming Island, FL 32006 |
| Contact | Nikole Goldsmith |
| Correspondent | Nikole Goldsmith NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC P.O. BOX 8507 Fleming Island, FL 32006 |
| Product Code | FZT |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-19 |
| Decision Date | 2011-09-12 |
| Summary: | summary |