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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, suction, lipoplasty for removal
510(k) Number K113128
Device Name MICROAIRE SURGICAL INSTRUMENTS LLC
Applicant
MICROAIRE SURGICAL INSTRUMENTS, LLC
7305 HANCOCK VILLAGE DR
SUITE 109
CHESTERFIELD,  VA  23832
Applicant Contact DARREN REEVES
Correspondent
MICROAIRE SURGICAL INSTRUMENTS, LLC
7305 HANCOCK VILLAGE DR
SUITE 109
CHESTERFIELD,  VA  23832
Correspondent Contact DARREN REEVES
Regulation Number878.5040
Classification Product Code
QPB  
Date Received10/24/2011
Decision Date 08/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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