The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for #500 Series Forceps W/cut/coagulate Switches.
| Device ID | K885199 |
| 510k Number | K885199 |
| Device Name: | #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES |
| 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 |