FDA 510(k) Application Details - K954136

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

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510(K) Number K954136
Device Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant MATRIX BIOKINETICS, INC.
4208 ARCATA WAY, UNIT C
NORTH LAS VEGAS, NV 89030 US
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Contact DEBORAH SORGNARD
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Regulation Number 890.5300

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Classification Product Code IMI
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Date Received 09/01/1995
Decision Date 04/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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