FDA 510(k) Application Details - K024013

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

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510(K) Number K024013
Device Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant SUN-RAIN SYSTEM CORP.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY TW
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Contact R. JEN KE-MIN
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Regulation Number 890.5300

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Classification Product Code IMI
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Date Received 12/04/2002
Decision Date 10/31/2003
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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