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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K962073
Device Name URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
Applicant
CONTINENTAL MEDICAL LABORATORIES, INC.
817 W.MOHR AVE.
P.O. BOX 306
WATERFORD,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
CONTINENTAL MEDICAL LABORATORIES, INC.
817 W.MOHR AVE.
P.O. BOX 306
WATERFORD,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number876.5130
Classification Product Code
FCM  
Date Received05/28/1996
Decision Date 06/21/1996
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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