The following data is part of a premarket notification filed by Roei Medical Technologies, Ltd. with the FDA for Modification To: Roei Working Element And Roei Cutting Loops.
| Device ID | K053322 |
| 510k Number | K053322 |
| Device Name: | MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-30 |
| Decision Date | 2006-01-06 |
| Summary: | summary |