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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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More FDA Info for this Product Code
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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