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FDA 510(k) Application Details - K102524
Device Classification Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K102524
Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant
DR. OLIVER WENKER, M.D., M.B.A.
2300 VALLEY VIEW LANE,
SUITE 230
FARMERS BRANCH, TX 75234 US
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Contact
COURTLAND IMEL
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Regulation Number
890.5860
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Classification Product Code
IMG
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More FDA Info for this Product Code
Date Received
09/02/2010
Decision Date
11/03/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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