The following data is part of a premarket notification filed by Olsen Medical with the FDA for Olsen Medical Integrated Irrigation Tubing And Bipolar Cord Set.
| Device ID | K072937 |
| 510k Number | K072937 |
| Device Name: | OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLSEN MEDICAL 3001 WEST KENTUCKY ST. Louisville, KY 40211 |
| Contact | John P Waters |
| Correspondent | John P Waters OLSEN MEDICAL 3001 WEST KENTUCKY ST. 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 | 2007-10-16 |
| Decision Date | 2007-12-28 |
| Summary: | summary |