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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number876.5250
Classification Product Code
EYZ  
Date Received06/16/1995
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
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