FDA 510(k) Application Details - K092044

Device Classification Name Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

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510(K) Number K092044
Device Name Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Applicant ORTHOCOR MEDICAL
9907 OAKLEAF WAY
MCCORDSVILLE, IN 46055 US
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Contact INES BURGOS
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Regulation Number 890.5290

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Classification Product Code ILX
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Date Received 07/06/2009
Decision Date 12/18/2009
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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