FDA 510(k) Application Details - K092066

Device Classification Name

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510(K) Number K092066
Device Name PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE
Applicant ANDREW TECHNOLOGIES, LLC
555 13TH ST., NW
WASHINGTON, DC 20004 US
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Contact JONATHAN S KAHAN
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Regulation Number

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Classification Product Code QPB
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Date Received 07/08/2009
Decision Date 04/12/2010
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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