The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Veritas Bipolar, Insulated, 0.5mm Tip, Model N301-005 Veritas Bipolar, Insulated 1.0mm Tip Model N301-010.
| Device ID | K982212 |
| 510k Number | K982212 |
| Device Name: | VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SYNERGETICS, INC. 88 HUBBLE DR. St. Charles, MO 63304 -8694 |
| Contact | Kurt Gampp |
| Correspondent | Kurt Gampp SYNERGETICS, INC. 88 HUBBLE DR. St. Charles, MO 63304 -8694 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-23 |
| Decision Date | 1998-12-02 |