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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 K863753
Device Name FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000
Applicant
Foundations Plus, Inc.
1008 Tinker Rd.
Colleyville,  TX  76034
Applicant Contact MARY USREY
Correspondent
Foundations Plus, Inc.
1008 Tinker Rd.
Colleyville,  TX  76034
Correspondent Contact MARY USREY
Regulation Number880.5240
Classification Product Code
KGX  
Date Received09/25/1986
Decision Date 10/30/1986
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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