Device Classification Name |
biopsy needle
|
510(k) Number |
K882549 |
Device Name |
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. |
Applicant |
ACUSON CORP. |
1220 CHARLESTON RD. |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Applicant Contact |
ROBERT J GALLAGHER |
Correspondent |
ACUSON CORP. |
1220 CHARLESTON RD. |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Correspondent Contact |
ROBERT J GALLAGHER |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 06/20/1988 |
Decision Date | 07/21/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|