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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 K932946
Device Name WALLACE IV CANNULA
Applicant
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE,  NH  03431
Applicant Contact TIMOTHY TALCOTT
Correspondent
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE,  NH  03431
Correspondent 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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