Device Classification Name |
subsystem, water purification
|
510(k) Number |
K133149 |
Device Name |
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM |
Applicant |
MAR COR PURIFICATION, INC. |
14605 28TH AVENUE NORTH |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
KINNARI SHAH |
Correspondent |
MAR COR PURIFICATION, INC. |
14605 28TH AVENUE NORTH |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
KINNARI SHAH |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 10/17/2013 |
Decision Date | 04/30/2014 |
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
|
|
|