Device Classification Name |
Accessories, Blood Circuit, Hemodialysis
|
510(k) Number |
K121599 |
Device Name |
CRIT-LINE CLIP (CLIC) |
Applicant |
FRESENIUS MEDICAL CARE-NORTH AMERICA |
920 Winter Street |
Waltham,
MA
02451
|
|
Applicant Contact |
DENISE OPPERMANN |
Correspondent |
FRESENIUS MEDICAL CARE-NORTH AMERICA |
920 Winter Street |
Waltham,
MA
02451
|
|
Correspondent Contact |
DENISE OPPERMANN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 11/09/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|