The following data is part of a premarket notification filed by Olsen Medical with the FDA for Electrosurgical Monopolar Cable/adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop.
| Device ID | K111262 |
| 510k Number | K111262 |
| Device Name: | ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLSEN MEDICAL 3230 COMMERCE CENTER PLACE Louisville, KY 40211 |
| Contact | Nunie Tabermejo |
| Correspondent | Nunie Tabermejo OLSEN MEDICAL 3230 COMMERCE CENTER PLACE Louisville, KY 40211 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-05 |
| Decision Date | 2012-05-23 |
| Summary: | summary |