FDA 510(k) Application Details - K022846

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

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510(K) Number K022846
Device Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant ITO CO., LTD.
2305 GOLD MINE RD.
BROOKEVILLE, MD 20833 US
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Contact T. WHIT ATHEY
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Regulation Number 890.5290

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Classification Product Code IMJ
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Date Received 08/27/2002
Decision Date 01/28/2003
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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