Device Classification Name |
Tank, Holding, Dialysis
|
510(k) Number |
K112427 |
Device Name |
BICARB MIXING AND DISTRIBUTION SYSTEM |
Applicant |
ISOPURE CORP. |
141 CITIZENS BLVD. |
SIMPSONVILLE,
KY
40067 -6548
|
|
Applicant Contact |
KEVIN C GILLESPIE |
Correspondent |
ISOPURE CORP. |
141 CITIZENS BLVD. |
SIMPSONVILLE,
KY
40067 -6548
|
|
Correspondent Contact |
KEVIN C GILLESPIE |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 08/23/2011 |
Decision Date | 01/26/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|