Device Classification Name |
endoscopic injection needle, gastroenterology-urology
|
510(k) Number |
K012977 |
Device Name |
VARICES INJECTION NEEDLE |
Applicant |
ENDO-THERAPEUTICS, INC. |
1183 CEDAR ST. |
SAFETY HARBOR,
FL
34695 -2908
|
|
Applicant Contact |
TODD ADKISSON |
Correspondent |
ENDO-THERAPEUTICS, INC. |
1183 CEDAR ST. |
SAFETY HARBOR,
FL
34695 -2908
|
|
Correspondent Contact |
TODD ADKISSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/05/2001 |
Decision Date | 11/02/2001 |
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
|
|
|