FDA 510(k) Application Details - K070931

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

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510(K) Number K070931
Device Name Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Applicant PROMEDTEK, INC.
1220 19TH ST., NW
SUITE 300
WASHINGTON, DC 20036 US
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Contact DIANE MANDELL
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Regulation Number 890.5290

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Classification Product Code ILX
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Date Received 04/03/2007
Decision Date 05/24/2007
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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