Device Classification Name |
Protector, Transducer, Dialysis
|
510(k) Number |
K812107 |
Device Name |
RENALAB TRANSDUCER PROTECTOR, .22 MICRON |
Applicant |
RENALAB |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
RENALAB |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5820 |
Classification Product Code |
|
Date Received | 07/27/1981 |
Decision Date | 08/20/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|