The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Olsen Laparoscopic Instr, Disposable, Single Use.
| Device ID | K912611 |
| 510k Number | K912611 |
| Device Name: | OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1992-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887482151976 | K912611 | 000 |
| 00887482151969 | K912611 | 000 |
| 00887482151952 | K912611 | 000 |