The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for 600 & 900 Series Electrodes & 755 & 756 Handle.
| Device ID | K885200 |
| 510k Number | K885200 |
| Device Name: | 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
| Contact | Eugene Olsen |
| Correspondent | Eugene 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 | 1988-12-16 |
| Decision Date | 1989-01-13 |