Device Classification Name |
angioscope
|
510(k) Number |
K914570 |
Device Name |
DISPOSABLE VASCULAR ANGIOSCOPE |
Applicant |
NOBLES-LAI |
3178 PULLMAN ST. |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
KAREN SALINAS |
Correspondent |
NOBLES-LAI |
3178 PULLMAN ST. |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
KAREN SALINAS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/15/1991 |
Decision Date | 01/27/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|