The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Loop, Models: El-160-4, El-160-8, El-200-4, El-200-8.
| Device ID | K070315 |
| 510k Number | K070315 |
| Device Name: | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | LINA MEDICAL APS 1289 N. FORDHAM BLVD. SUITE A-128 Chapel Hill, NC 27517 |
| Contact | Walt Brittle |
| Correspondent | Walt Brittle LINA MEDICAL APS 1289 N. FORDHAM BLVD. SUITE A-128 Chapel Hill, NC 27517 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-01 |
| Decision Date | 2007-10-30 |
| Summary: | summary |