Device Classification Name |
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
|
510(k) Number |
K070315 |
Device Name |
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 |
Applicant |
LINA MEDICAL APS |
1289 N. FORDHAM BLVD. |
SUITE A-128 |
CHAPEL HILL,
NC
27517
|
|
Applicant Contact |
WALT BRITTLE |
Correspondent |
LINA MEDICAL APS |
1289 N. FORDHAM BLVD. |
SUITE A-128 |
CHAPEL HILL,
NC
27517
|
|
Correspondent Contact |
WALT BRITTLE |
Regulation Number | 884.4160
|
Classification Product Code |
|
Date Received | 02/01/2007 |
Decision Date | 10/30/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|