FDA 510(k) Application Details - K052340

Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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510(K) Number K052340
Device Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant ALFA TECH MEDICAL SYSTEMS, LTD.
55 NORTHERN BLVD., STE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 890.5860

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Classification Product Code IMG
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Date Received 08/26/2005
Decision Date 12/09/2005
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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