The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Teflon Coated Electrodes/electrodes Handles.
| Device ID | K913108 |
| 510k Number | K913108 |
| Device Name: | TEFLON COATED ELECTRODES/ELECTRODES HANDLES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
| Contact | Eugene W Olsen |
| Correspondent | Eugene W Olsen OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-12 |
| Decision Date | 1991-12-23 |