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FDA 510(k) Application Details - K092066
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QPB
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More FDA Info for this Product Code
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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