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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter,intravascular,therapeutic,short-term less than 30 days
510(k) Number K932947
Device Name WALLACE Y-CAN
Original Applicant
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 kit st.
keene,  NH  03431
Original Contact timothy talcott
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/17/1993
Decision Date 09/01/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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