The following data is part of a premarket notification filed by Ksea with the FDA for Ksea Bipolar Electrotome.
| Device ID | K061541 |
| 510k Number | K061541 |
| Device Name: | KSEA BIPOLAR ELECTROTOME |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | KSEA 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | James A Lee |
| Correspondent | James A Lee KSEA 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-05 |
| Decision Date | 2006-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551075623 | K061541 | 000 |