Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K141902 |
Device Name |
LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER |
Applicant |
LAGIS ENTERPRISES CO, LTD. |
NO. 29, GONG 1ST RD., DAJIA |
TAICHUNG,
TW
437
|
|
Applicant Contact |
CORA CHEN |
Correspondent |
LAGIS ENTERPRISES CO, LTD. |
NO. 29, GONG 1ST RD., DAJIA |
TAICHUNG,
TW
437
|
|
Correspondent Contact |
CORA CHEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/14/2014 |
Decision Date | 05/26/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|