Device Classification Name |
endoscopic injection needle, gastroenterology-urology
|
510(k) Number |
K960519 |
Device Name |
MARTECH ENDOSCOPIC INJECTION NEEDLE |
Applicant |
MARTECH MEDICAL PRODUCTS, INC. |
1500 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
DAVID ROBERTS |
Correspondent |
MARTECH MEDICAL PRODUCTS, INC. |
1500 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
DAVID ROBERTS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/05/1996 |
Decision Date | 05/01/1996 |
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
|
|
|