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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K905572
Device Name EDLICH WOUND MANAGEMENT TRAY
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 Number880.5075
Classification Product Code
MCY  
Date Received12/12/1990
Decision Date 03/12/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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