The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Titanium Bipolar Forceps.
| Device ID | K940466 |
| 510k Number | K940466 |
| Device Name: | TITANIUM BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RADIONICS, INC. P.O. BOX 438 22 TERRY AVENUE Burlington, MA 01803 -2591 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS, INC. P.O. BOX 438 22 TERRY AVENUE Burlington, MA 01803 -2591 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1994-04-21 |