Device Classification Name |
punch, biopsy
|
510(k) Number |
K875119 |
Device Name |
BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE |
Applicant |
ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. |
6905 SIERRA COURT |
DUBLIN,
CA
94568
|
|
Applicant Contact |
J ALLSEBROOK |
Correspondent |
ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. |
6905 SIERRA COURT |
DUBLIN,
CA
94568
|
|
Correspondent Contact |
J ALLSEBROOK |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 12/15/1987 |
Decision Date | 03/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|