The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Gold Loop Hc.
| Device ID | K132135 |
| 510k Number | K132135 |
| Device Name: | LINA GOLD LOOP HC |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | LINA MEDICAL APS 386 WEST MAIN ST. SUITE 7 Northborough, MA 01532 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-10 |
| Decision Date | 2014-01-31 |
| Summary: | summary |