Device Classification Name |
Protector, Transducer, Dialysis
|
510(k) Number |
K870394 |
Device Name |
HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS |
Applicant |
CLINICAL CONNECTIONS, INC. |
P.O. BOX 238 |
9287 SMUCKER ROAD |
ORRVILLE,
OH
44667
|
|
Applicant Contact |
KEITH ANTAL |
Correspondent |
CLINICAL CONNECTIONS, INC. |
P.O. BOX 238 |
9287 SMUCKER ROAD |
ORRVILLE,
OH
44667
|
|
Correspondent Contact |
KEITH ANTAL |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 01/30/1987 |
Decision Date | 03/03/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|