Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K122294 |
Device Name |
PRESSURIZED INFUSION PUMP |
Applicant |
MUI SCIENTIFIC |
145 TRADERS BLVD. EAST, # 34 |
MISSISSAUGA,
CA
L4Z 3L3
|
|
Applicant Contact |
TAMMY MUI |
Correspondent |
MUI SCIENTIFIC |
145 TRADERS BLVD. EAST, # 34 |
MISSISSAUGA,
CA
L4Z 3L3
|
|
Correspondent Contact |
TAMMY MUI |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 07/31/2012 |
Decision Date | 11/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|