Device Classification Name |
Ligator, Hemorrhoidal
|
510(k) Number |
K091519 |
Device Name |
HAEMOBAND MULTI-LIGATOR |
Applicant |
HAEMOBAND SURGICAL LTD. |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
HAEMOBAND SURGICAL LTD. |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 876.4400
|
Classification Product Code |
|
Date Received | 05/22/2009 |
Decision Date | 07/28/2009 |
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
|
|
|