Device Classification Name |
coagulator-cutter, endoscopic, unipolar (and accessories)
|
510(k) Number |
K132135 |
Device Name |
LINA GOLD LOOP HC |
Applicant |
LINA MEDICAL APS |
386 WEST MAIN ST. SUITE 7 |
NORTHBOROUGH,
MA
01532
|
|
Correspondent |
LINA MEDICAL APS |
386 WEST MAIN ST. SUITE 7 |
NORTHBOROUGH,
MA
01532
|
|
Regulation Number | 884.4160
|
Classification Product Code |
|
Date Received | 07/10/2013 |
Decision Date | 01/31/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|