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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
510(k) Number K150779
Device Name LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
Applicant
MICROAIRE SURGICAL INSTRUMENTS, LLC
3590 Grand Forks Blvd
Charlottesville,  VA  22911
Applicant Contact Chris Spofford
Correspondent
MICROAIRE SURGICAL INSTRUMENTS, LLC
3590 Grand Forks Blvd
Charlottesville,  VA  22911
Correspondent Contact Chris Spofford
Regulation Number878.5040
Classification Product Code
MUU  
Date Received03/25/2015
Decision Date 05/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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