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 |