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FDA 510(k) Application Details - K091615
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K091615
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
GENERAL PROJECT S.R.L.
5 TIMBER LANE
NORTH READING, MA 01864 US
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Contact
MAUREEN O'CONNELL
Other 510(k) Applications for this Contact
Regulation Number
890.5300
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Classification Product Code
IMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/03/2009
Decision Date
05/06/2010
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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