The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Xcise Model Mor-1515.
| Device ID | K101458 |
| 510k Number | K101458 |
| Device Name: | LINA XCISE MODEL MOR-1515 |
| Classification | Laparoscope, Gynecologic (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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-26 |
| Decision Date | 2011-03-11 |
| Summary: | summary |