Device Classification Name |
endoscopic injection needle, gastroenterology-urology
|
510(k) Number |
K010448 |
Device Name |
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES |
Applicant |
HORIZONS INTL. CORP. |
287 MONTERREY ST. |
PONCE,
PR
00732
|
|
Applicant Contact |
RAFIC SALEH |
Correspondent |
HORIZONS INTL. CORP. |
287 MONTERREY ST. |
PONCE,
PR
00732
|
|
Correspondent Contact |
RAFIC SALEH |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/15/2001 |
Decision Date | 05/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|