The following data is part of a premarket notification filed by Roei Medical Technologies, Ltd. with the FDA for Roei Working Element And Roel Cutting Loops.
| Device ID | K050910 |
| 510k Number | K050910 |
| Device Name: | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | ROEI MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahn |
| Correspondent | Jonathan S Kahn ROEI MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-11 |
| Decision Date | 2005-06-16 |
| Summary: | summary |