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FDA 510(k) Application Details - K141708
Device Classification Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
More FDA Info for this Device
510(K) Number
K141708
Device Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant
SYNERON MEDICAL LTD.
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact
JANICE M HOGAN
Other 510(k) Applications for this Contact
Regulation Number
878.4590
More FDA Info for this Regulation Number
Classification Product Code
OHV
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More FDA Info for this Product Code
Date Received
06/24/2014
Decision Date
10/06/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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