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FDA 510(k) Application Details - K000084
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
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510(K) Number
K000084
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
HENLEY HEALTHCARE, INC.
120 INDUSTRIAL BLVD.
SUGAR LAND, TX 77478 US
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Contact
REBECCA STOUT
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Regulation Number
890.5300
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Classification Product Code
IMI
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More FDA Info for this Product Code
Date Received
01/12/2000
Decision Date
08/04/2000
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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