Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K931595 |
Device Name |
REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION |
Applicant |
OSMONICS, INC. |
5951 CLEARWATER DR. |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
MARK A PAULSON |
Correspondent |
OSMONICS, INC. |
5951 CLEARWATER DR. |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
MARK A PAULSON |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 03/31/1993 |
Decision Date | 12/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|