Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K932306 |
Device Name |
MICROINFUSOR |
Applicant |
SANDHILL SCIENTIFIC, INC. |
1501-N WEST CAMPUS DR. |
LITTLETON,
CO
80120 -4535
|
|
Applicant Contact |
JUDY K GRIFFITH |
Correspondent |
SANDHILL SCIENTIFIC, INC. |
1501-N WEST CAMPUS DR. |
LITTLETON,
CO
80120 -4535
|
|
Correspondent Contact |
JUDY K GRIFFITH |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 05/11/1993 |
Decision Date | 04/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|