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FDA 510(k) Application Details - K070779
Device Classification Name
System, Ablation, Ultrasound And Accessories
More FDA Info for this Device
510(K) Number
K070779
Device Name
System, Ablation, Ultrasound And Accessories
Applicant
MISONIX, INC.
1938 NEW HIGHWAY
FARMINGDALE, NY 11735 US
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Contact
RONALD MANNA
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
NTB
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More FDA Info for this Product Code
Date Received
03/21/2007
Decision Date
07/09/2008
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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