Device Classification Name |
Biopsy Needle
|
510(k) Number |
K945921 |
Device Name |
ECHO STAR NEEDLE SET |
Applicant |
IDEAMATRIX |
3321 ROCKWOOD LN. SOUTH |
ESTES PARK,
CO
80517
|
|
Applicant Contact |
RICHARD TERWILLIGER |
Correspondent |
IDEAMATRIX |
3321 ROCKWOOD LN. SOUTH |
ESTES PARK,
CO
80517
|
|
Correspondent Contact |
RICHARD TERWILLIGER |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 12/05/1994 |
Decision Date | 02/01/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|