Device Classification Name |
Set, Administration, For Peritoneal Dialysis, Disposable
|
510(k) Number |
K820546 |
Device Name |
CARD U.V. GERMICIDAL CHAMBER II |
Applicant |
TRAVENOL LABORATORIES, S.A. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
TRAVENOL LABORATORIES, S.A. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 03/02/1982 |
Decision Date | 06/30/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|