The following data is part of a premarket notification filed by Synergetics with the FDA for Spetzler Malis Dual Illuminating Bipolar Forceps.
| Device ID | K160103 |
| 510k Number | K160103 |
| Device Name: | Spetzler Malis Dual Illuminating Bipolar Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SYNERGETICS 3845 CORPORATE CENTRE DRIVE O' Fallon, MO 63368 |
| Contact | Dan Regan |
| Correspondent | Dan Regan SYNERGETICS 3845 CORPORATE CENTRE DRIVE O' Fallon, MO 63368 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-10-12 |
| Summary: | summary |