Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K120823 |
Device Name |
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
920 Winter Street |
Waltham,
MA
02451 -1457
|
|
Applicant Contact |
DENISE OPPERMANN |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
920 Winter Street |
Waltham,
MA
02451 -1457
|
|
Correspondent Contact |
DENISE OPPERMANN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/19/2012 |
Decision Date | 06/15/2012 |
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
|
|
|