Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K944493 |
Device Name |
REVERSE OSMOSIS SYSTEM |
Applicant |
G.E.M. WATER SYSTEMS |
5940 LAKESHORE DR. |
CYPRESS,
CA
90630
|
|
Applicant Contact |
JACK ENKOWITZ |
Correspondent |
G.E.M. WATER SYSTEMS |
5940 LAKESHORE DR. |
CYPRESS,
CA
90630
|
|
Correspondent Contact |
JACK ENKOWITZ |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 09/13/1994 |
Decision Date | 02/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|