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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K915495
Device Name DESERET POSITIONAL SUTURE WING
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
9450 S. State Sreet
Sandy,  UT  84070
Applicant Contact CHARLES WELLE
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
9450 S. State Sreet
Sandy,  UT  84070
Correspondent Contact CHARLES WELLE
Regulation Number880.5210
Classification Product Code
KMK  
Date Received12/09/1991
Decision Date 04/06/1992
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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