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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 K192694
Device Name PAL Single-Use Cannulas
Applicant
Microaire Surgical Instruments
3590 Grand Forks Blvd.
Charlottesville,  VA  22911
Applicant Contact Glenn Gerstenfeld
Correspondent
Barile & Associates, Inc.
P.O. Box 5199
Clinton,  NJ  08809
Correspondent Contact Diane Sudduth
Regulation Number878.5040
Classification Product Code
QPB  
Date Received09/26/2019
Decision Date 05/14/2020
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
Predetermined Change
Control Plan Authorized		 No
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