Device Classification Name |
Set, Perfusion, Kidney, Disposable
|
510(k) Number |
K780470 |
Device Name |
H.P. MEDICAL GRADE SILICONE TUBING |
Applicant |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 03/22/1978 |
Decision Date | 04/27/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|