Device Classification Name |
Protector, Transducer, Dialysis
|
510(k) Number |
K910821 |
Device Name |
TRANSDUCER PROTECTOR |
Applicant |
GELMAN SCIENCES, INC. |
600 SOUTH WAGNER RD. |
ANN ARBOR,
MI
48103 -9019
|
|
Applicant Contact |
HARWOOD GREEN |
Correspondent |
GELMAN SCIENCES, INC. |
600 SOUTH WAGNER RD. |
ANN ARBOR,
MI
48103 -9019
|
|
Correspondent Contact |
HARWOOD GREEN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 02/26/1991 |
Decision Date | 08/12/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|