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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ventricular, general & plastic surgery
510(k) Number K813463
Device Name SIL-V-UR CHEST CATHETER
Applicant
C.R. BARD, INC.
110 MARSHALL DRIVE
WARRANDALE,  PA  15086
Correspondent
C.R. BARD, INC.
110 MARSHALL DRIVE
WARRANDALE,  PA  15086
Regulation Number878.4200
Classification Product Code
GBS  
Date Received12/11/1981
Decision Date 02/12/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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