Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K970446 |
Device Name |
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM |
Applicant |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
13520 S.E. PHEASANT COURT |
PORTLAND,
OR
97222 -1298
|
|
Applicant Contact |
THOMAS D KELLY |
Correspondent |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
13520 S.E. PHEASANT COURT |
PORTLAND,
OR
97222 -1298
|
|
Correspondent Contact |
THOMAS D KELLY |
Regulation Number | 876.5860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/05/1997 |
Decision Date | 06/02/1997 |
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
|