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FDA 510(k) Application Details - K131309
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K131309
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
IBRAMED EQUIPAMENTOS MEDICOS
18851 NE 29TH AVE 720
AVENTURA, FL 33180 US
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Contact
TARA CONRAD
Other 510(k) Applications for this Contact
Regulation Number
890.5300
More FDA Info for this Regulation Number
Classification Product Code
IMI
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More FDA Info for this Product Code
Date Received
05/07/2013
Decision Date
01/27/2014
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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