Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K032004 |
Device Name |
AQUABOSS ECORO DIA 50 |
Applicant |
LAUER LTD., HONG KONG |
SPEICHERMATT 9 |
WITTLINGEN,
DE
79599
|
|
Applicant Contact |
STEPHAN KRIETEMEYER |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
STEFAN PREISS |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 06/30/2003 |
Decision Date | 10/02/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|