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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 K942753
Device Name ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER
Applicant
Researched, Novel Medical Devices (Rn/Md)
4480 Sherman Oaks Cir.
Sherman Oaks,  CA  91403
Applicant Contact ANNABELLE D TUCKER
Correspondent
Researched, Novel Medical Devices (Rn/Md)
4480 Sherman Oaks Cir.
Sherman Oaks,  CA  91403
Correspondent Contact ANNABELLE D TUCKER
Regulation Number876.5250
Classification Product Code
EYZ  
Date Received06/10/1994
Decision Date 11/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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