The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Modified Olsen 755/756 Switchpens.
| Device ID | K884174 |
| 510k Number | K884174 |
| Device Name: | MODIFIED OLSEN 755/756 SWITCHPENS |
| Classification | Apparatus, Electrosurgical |
| 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 | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-30 |
| Decision Date | 1988-10-24 |