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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 K911070
Device Name PICC-FIX
Applicant
Sorex Medical
5725 W. Harold Gatty Dr.
Salt Lake City,  UT  84116
Applicant Contact JOSEPH SORENSON
Correspondent
Sorex Medical
5725 W. Harold Gatty Dr.
Salt Lake City,  UT  84116
Correspondent Contact JOSEPH SORENSON
Regulation Number880.5210
Classification Product Code
KMK  
Date Received03/11/1991
Decision Date 07/05/1991
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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