Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K981003 |
Device Name |
ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES |
Applicant |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
7307 GLOUCHESTER DR. |
EDINA,
MN
55435
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
7307 GLOUCHESTER DR. |
EDINA,
MN
55435
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/18/1998 |
Decision Date | 06/16/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|