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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K102524
Device Name FUTURA
Applicant
Dr. Oliver Wenker, M.D., M.B.A.
2300 Valley View Ln. Suite 230
Farmers Branch,  TX  75234
Applicant Contact COURTLAND IMEL
Correspondent
Dr. Oliver Wenker, M.D., M.B.A.
2300 Valley View Ln. Suite 230
Farmers Branch,  TX  75234
Correspondent Contact COURTLAND IMEL
Regulation Number890.5860
Classification Product Code
IMG  
Date Received09/02/2010
Decision Date 11/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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