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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, long-term greater than 30 days
510(k) Number K926331
Device Name 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH
Applicant
BARD ACCESS SYSTEMS, INC.
5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY,  UT  84116
Applicant Contact JACK SPEER
Correspondent
BARD ACCESS SYSTEMS, INC.
5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact JACK SPEER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/16/1992
Decision Date 03/07/1994
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
Recalls CDRH Recalls
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