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FDA 510(k) Application Details - K052340
Device Classification Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
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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More FDA Info for this Product Code
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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