Device Classification Name |
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
|
510(k) Number |
K952780 |
Device Name |
URINARY GEL DRAINAGE SYSTEM |
Applicant |
P.A.M., INC. |
915 CARTERS CREEK PIKE |
COLUMBIA,
TN
38401
|
|
Applicant Contact |
JAMES F LAMBERT |
Correspondent |
P.A.M., INC. |
915 CARTERS CREEK PIKE |
COLUMBIA,
TN
38401
|
|
Correspondent Contact |
JAMES F LAMBERT |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 06/16/1995 |
Decision Date | 12/12/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|