FDA 510(k) Application Details - K024307

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

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510(K) Number K024307
Device Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant SYBARITIC, INC.
9220 JAMES AVE. SOUTH
BLOOMINGTON, MN 55431 US
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Contact RANDALL E BERGLUND
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Regulation Number 890.5300

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Classification Product Code IMI
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Date Received 12/24/2002
Decision Date 07/02/2003
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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