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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 K034020
Device Name GROSHONG NXT PICC CATHETERS
Applicant
C.R. Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Applicant Contact PEGGY KEIFFER
Correspondent
C.R. Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact PEGGY KEIFFER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/24/2003
Decision Date 01/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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