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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K950438
Device Name SAFEDWEEL DRESSING CHANGE TRAY
Applicant
Becton Dickinson Vascular Access, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact C. J WELLE
Correspondent
Becton Dickinson Vascular Access, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact C. J WELLE
Regulation Number880.6850
Classification Product Code
FRG  
Date Received02/02/1995
Decision Date 03/15/1995
Decision Substantially Equivalent - Kit (SESK)
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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