Device Classification Name |
subsystem, water purification
|
510(k) Number |
K013677 |
Device Name |
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM |
Applicant |
U.S. FILTER/IONPURE, INC. |
10 TECHNOLOGY DR. |
LOWELL,
MA
01851
|
|
Applicant Contact |
DAVID A DENTINO |
Correspondent |
U.S. FILTER/IONPURE, INC. |
10 TECHNOLOGY DR. |
LOWELL,
MA
01851
|
|
Correspondent Contact |
DAVID A DENTINO |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 11/07/2001 |
Decision Date | 03/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|