Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K083542 |
Device Name |
FRESENIUS STERILE STAY SAFE CAP |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street |
Waltham,
MA
02451 -1457
|
|
Applicant Contact |
JANET KAY |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street |
Waltham,
MA
02451 -1457
|
|
Correspondent Contact |
JANET KAY |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 11/28/2008 |
Decision Date | 12/29/2008 |
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
|
|
|