FDA 510(k) Application Details - K041058

Device Classification Name

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510(K) Number K041058
Device Name MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
Applicant MISONIX, INC.
1938 NEW HIGHWAY
FARMINGDALE, NY 11735 US
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Contact RONALD R MANNA
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Regulation Number

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Classification Product Code QPB
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Date Received 04/23/2004
Decision Date 05/17/2004
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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