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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K950439
Device Name INSYTE SIDEHOLDED DRAINAGE CATHETER
Applicant
BECTON DICKINSON VASCULAR ACCESS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Applicant Contact C. J WELLE
Correspondent
BECTON DICKINSON VASCULAR ACCESS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Correspondent Contact C. J WELLE
Regulation Number878.4200
Classification Product Code
GBX  
Date Received02/02/1995
Decision Date 03/14/1995
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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