FDA 510(k) Application Details - K070779

Device Classification Name System, Ablation, Ultrasound And Accessories

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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
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Regulation Number 878.4400

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Classification Product Code NTB
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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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