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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K864477
Device Name FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000
Applicant
Foundations Plus, Inc.
1008 Tinker Rd.
Colleyville,  TX  76034
Applicant Contact DIETRICH USREY
Correspondent
Foundations Plus, Inc.
1008 Tinker Rd.
Colleyville,  TX  76034
Correspondent Contact DIETRICH USREY
Date Received11/13/1986
Decision Date 12/02/1986
Decision Substantially Equivalent (SESE)
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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