Device Classification Name |
Snare, Flexible
|
510(k) Number |
K083049 |
Device Name |
TORNADO ROTATABEL SNARE AND POLYP CATCHER |
Applicant |
HORIZONS INTL. CORP. |
P.O. BOX 213-3006 |
ZONA FRANCA METRO |
BARREAL DE HEREDIA,
CR
|
|
Applicant Contact |
RAFIC SALEH |
Correspondent |
HORIZONS INTL. CORP. |
P.O. BOX 213-3006 |
ZONA FRANCA METRO |
BARREAL DE HEREDIA,
CR
|
|
Correspondent Contact |
RAFIC SALEH |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 10/14/2008 |
Decision Date | 12/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|