Device Classification Name |
subsystem, water purification
|
510(k) Number |
K031832 |
Device Name |
MEGA PURE CART |
Applicant |
MEGA SERVICES |
106 LOST MEADOWS DRIVE |
CIBOLO,
TX
78108
|
|
Applicant Contact |
ROBERT OLIVER |
Correspondent |
MEGA SERVICES |
106 LOST MEADOWS DRIVE |
CIBOLO,
TX
78108
|
|
Correspondent Contact |
ROBERT OLIVER |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 06/13/2003 |
Decision Date | 10/20/2004 |
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
|
|
|