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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K871138
Device Name FOUNDATIONS PLUS ABDOMINAL BAND 1100
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 Received03/23/1987
Decision Date 04/23/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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