The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size.
| Device ID | K130305 |
| 510k Number | K130305 |
| Device Name: | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | LINA MEDICAL APS 611 WEST 5TH STRRET THIRD FLOOR Austin, TX 78701 |
| Contact | Richard Gillis |
| Correspondent | Richard Gillis LINA MEDICAL APS 611 WEST 5TH STRRET THIRD FLOOR Austin, TX 78701 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-05 |
| Decision Date | 2013-07-24 |
| Summary: | summary |