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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 K904558
Device Name DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
Applicant
DAVOL, INC.
3385 WEST 1820
SALT LAKE CITY,  UT  84104
Applicant Contact JACK SPEER
Correspondent
DAVOL, INC.
3385 WEST 1820
SALT LAKE CITY,  UT  84104
Correspondent Contact JACK SPEER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/05/1990
Decision Date 02/11/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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