Device Classification Name |
biopsy needle
|
510(k) Number |
K892068 |
Device Name |
TRT (ACUSON) NEEDLE GUIDE KIT, STERILE |
Applicant |
AMEDIC USA |
OXENSTIERNSGATAN 31 |
115 27 STOCKHOLM |
SWEDEN,
SE
|
|
Applicant Contact |
ANDERS WEILANDT |
Correspondent |
AMEDIC USA |
OXENSTIERNSGATAN 31 |
115 27 STOCKHOLM |
SWEDEN,
SE
|
|
Correspondent Contact |
ANDERS WEILANDT |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 03/30/1989 |
Decision Date | 08/04/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|