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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K863305
Device Name HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
Applicant
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Applicant Contact CATHERINE V BEATH
Correspondent
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Correspondent Contact CATHERINE V BEATH
Regulation Number880.5965
Classification Product Code
LJT  
Date Received08/25/1986
Decision Date 10/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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