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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K914733
Device Name TTL MEDICATED DRESSING
Applicant
Medimix Products, Inc.
10635 Dutchtown Rd., NW
Knoxville,  TN  37932
Applicant Contact BRIAN DAVIES
Correspondent
Medimix Products, Inc.
10635 Dutchtown Rd., NW
Knoxville,  TN  37932
Correspondent Contact BRIAN DAVIES
Regulation Number880.5240
Classification Product Code
KGX  
Date Received10/21/1991
Decision Date 07/01/1992
Decision Substantially Equivalent (SESE)
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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