Device Classification Name |
system, gastrointestinal motility (electrical)
|
510(k) Number |
K002427 |
Device Name |
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 |
Applicant |
SANDHILL SCIENTIFIC, INC. |
9150 COMMERCE CENTER CIR.,#500 |
HIGHLANDS RANCH,
CO
80129
|
|
Applicant Contact |
LIUNDA L DIEDERICH |
Correspondent |
SANDHILL SCIENTIFIC, INC. |
9150 COMMERCE CENTER CIR.,#500 |
HIGHLANDS RANCH,
CO
80129
|
|
Correspondent Contact |
LIUNDA L DIEDERICH |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 08/08/2000 |
Decision Date | 06/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|