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FDA 510(k) Application Details - K070931
Device Classification Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K070931
Device Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Applicant
PROMEDTEK, INC.
1220 19TH ST., NW
SUITE 300
WASHINGTON, DC 20036 US
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Contact
DIANE MANDELL
Other 510(k) Applications for this Contact
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
04/03/2007
Decision Date
05/24/2007
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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