The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Smoke/odor Evacuator #757.
| Device ID | K912612 |
| 510k Number | K912612 |
| Device Name: | SMOKE/ODOR EVACUATOR #757 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
| Contact | Maria Mursell |
| Correspondent | Maria Mursell OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1991-11-01 |