The following data is part of a premarket notification filed by Olsen Medical with the FDA for Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps.
| Device ID | K080187 |
| 510k Number | K080187 |
| Device Name: | OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS |
| 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 | 2008-01-25 |
| Decision Date | 2008-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841785106133 | K080187 | 000 |
| 30841785102302 | K080187 | 000 |
| 30841785102296 | K080187 | 000 |
| 30841785102272 | K080187 | 000 |
| 30841785102265 | K080187 | 000 |
| 30841785102258 | K080187 | 000 |
| 30841785102234 | K080187 | 000 |
| 30841785102227 | K080187 | 000 |
| 30841785102197 | K080187 | 000 |
| 30841785102173 | K080187 | 000 |
| 30841785102326 | K080187 | 000 |
| 30841785102333 | K080187 | 000 |
| 00841785102363 | K080187 | 000 |
| 30841785102524 | K080187 | 000 |
| 30841785102517 | K080187 | 000 |
| 30841785102494 | K080187 | 000 |
| 30841785102487 | K080187 | 000 |
| 30841785102432 | K080187 | 000 |
| 30841785102425 | K080187 | 000 |
| 30841785102401 | K080187 | 000 |
| 30841785102395 | K080187 | 000 |
| 30841785102371 | K080187 | 000 |
| 30841785102166 | K080187 | 000 |