The following data is part of a premarket notification filed by Olsen Medical with the FDA for Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps.
| Device ID | K130669 |
| 510k Number | K130669 |
| Device Name: | SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLSEN MEDICAL 1927 N. ARTHUR DR. Columbia City, IN 46725 |
| Contact | Dalene Binkley |
| Correspondent | Dalene Binkley OLSEN MEDICAL 1927 N. ARTHUR DR. Columbia City, IN 46725 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2013-12-06 |
| Summary: | summary |