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FDA 510(k) Application Details - K092044
Device Classification Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
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510(K) Number
K092044
Device Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Applicant
ORTHOCOR MEDICAL
9907 OAKLEAF WAY
MCCORDSVILLE, IN 46055 US
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Contact
INES BURGOS
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Regulation Number
890.5290
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Classification Product Code
ILX
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More FDA Info for this Product Code
Date Received
07/06/2009
Decision Date
12/18/2009
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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