The following data is part of a premarket notification filed by Iti Medical Technologies, Inc. with the FDA for Midas Touch Bipolar Forceps.
| Device ID | K982705 |
| 510k Number | K982705 |
| Device Name: | MIDAS TOUCH BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ITI MEDICAL TECHNOLOGIES, INC. 2452 ARMSTRONG ST. Livermore, CA 94550 |
| Contact | Roger Werne |
| Correspondent | Roger Werne ITI MEDICAL TECHNOLOGIES, INC. 2452 ARMSTRONG ST. Livermore, CA 94550 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-03 |
| Decision Date | 1998-09-08 |
| Summary: | summary |