The following data is part of a premarket notification filed by Jac-cell Medic with the FDA for Jac-cell Medic Testers.
| Device ID | K170105 |
| 510k Number | K170105 |
| Device Name: | Jac-Cell Medic Testers |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JAC-CELL MEDIC 5764 Pare Street Tmr Mont - Royal, CA H4p 2m2 |
| Contact | Mark Meltzer |
| Correspondent | Jay Mansour Mansour Company LLC 845 Aronson Lake Court Roswell, GA 30075 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-12 |
| Decision Date | 2017-02-28 |
| Summary: | summary |