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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K910315
Device Name PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K
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 Number880.5970
Classification Product Code
LJS  
Date Received01/24/1991
Decision Date 04/05/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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