Device Classification Name |
Ligator, Hemorrhoidal
|
510(k) Number |
K150718 |
Device Name |
Wi-3 HAL-RAR System |
Applicant |
AGENCY FOR MEDICAL INNOVATIONS GMBH |
IM LETTEN 1 |
FELDKIRCH, VORARLBERG,
AT
6800
|
|
Applicant Contact |
Stefanie Hoellger |
Correspondent |
AcKnowledge Regulatory Strategies |
2834 Hawthorn St. |
San Diego,
CA
92104
|
|
Correspondent Contact |
Allison C Komiyama |
Regulation Number | 876.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/19/2015 |
Decision Date | 06/12/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|