FDA 510(k) Application Details - K120093

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

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510(K) Number K120093
Device Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant BTL INDUSTRIES, INC
16 APPLETON STREET
WALTHAM, MA 02453 US
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Contact Marcy Moore
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Regulation Number 890.5290

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Classification Product Code IMJ
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Date Received 01/12/2012
Decision Date 10/05/2012
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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