Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K904231 |
Device Name |
MODEL OSP, SANDHILL AMS |
Applicant |
SANDHILL SCIENTIFIC, INC. |
1501-N WEST CAMPUS DR. |
LITTLETON,
CO
80120 -4535
|
|
Applicant Contact |
JUDY GRIFFITH |
Correspondent |
SANDHILL SCIENTIFIC, INC. |
1501-N WEST CAMPUS DR. |
LITTLETON,
CO
80120 -4535
|
|
Correspondent Contact |
JUDY GRIFFITH |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 08/28/1990 |
Decision Date | 01/02/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|