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FDA 510(k) Application Details - K123980
Device Classification Name
Wound Cleaner, Ultrasound
More FDA Info for this Device
510(K) Number
K123980
Device Name
Wound Cleaner, Ultrasound
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
878.4410
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Classification Product Code
NRB
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More FDA Info for this Product Code
Date Received
12/26/2012
Decision Date
03/05/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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