Device Classification Name |
endoscopic injection needle, gastroenterology-urology
|
510(k) Number |
K990996 |
Device Name |
GENYX MEDICAL INJECTION NEEDLE |
Applicant |
GENYX MEDICAL, INC. |
36 ARGONAUT, SUITE 100 |
ALISO VIEJO,
CA
92656 -1467
|
|
Applicant Contact |
JUDY F GORDON |
Correspondent |
GENYX MEDICAL, INC. |
36 ARGONAUT, SUITE 100 |
ALISO VIEJO,
CA
92656 -1467
|
|
Correspondent Contact |
JUDY F GORDON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/25/1999 |
Decision Date | 06/18/1999 |
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
|
|
|