The following data is part of a premarket notification filed by Pollogen Ltd with the FDA for Surgen U.
| Device ID | K131758 |
| 510k Number | K131758 |
| Device Name: | SURGEN U |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | POLLOGEN LTD 555 THIRTEENTH ST, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan POLLOGEN LTD 555 THIRTEENTH ST, NW Washington, DC 20004 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-12-18 |
| Summary: | summary |