Device Classification Name |
subsystem, water purification
|
510(k) Number |
K964539 |
Device Name |
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST |
Applicant |
ZYZATECH WATER SYSTEMS, INC. |
7848 S. 202ND ST. |
KENT,
WA
98032
|
|
Applicant Contact |
JOHN MILLER |
Correspondent |
ZYZATECH WATER SYSTEMS, INC. |
7848 S. 202ND ST. |
KENT,
WA
98032
|
|
Correspondent Contact |
JOHN MILLER |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 11/12/1996 |
Decision Date | 11/26/1997 |
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
|
|
|