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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 K930556
Device Name NIGHT URINARY DRAINAGE BEDSIDE BAG
Applicant
EZMT VALVE CO., INC.
22260 DAVENRICH ST.
SALINAS,  CA  93908
Applicant Contact RAYMOND E GRIFFIN
Correspondent
EZMT VALVE CO., INC.
22260 DAVENRICH ST.
SALINAS,  CA  93908
Correspondent Contact RAYMOND E GRIFFIN
Regulation Number876.5250
Classification Product Code
EYZ  
Date Received02/03/1993
Decision Date 05/14/1993
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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