PAL Single-Use Cannulas

System, Suction, Lipoplasty

MicroAire Surgical Instruments

The following data is part of a premarket notification filed by Microaire Surgical Instruments with the FDA for Pal Single-use Cannulas.

Pre-market Notification Details

Device IDK192694
510k NumberK192694
Device Name:PAL Single-Use Cannulas
ClassificationSystem, Suction, Lipoplasty
Applicant MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville,  VA  22911
ContactGlenn Gerstenfeld
CorrespondentDiane Sudduth
Barile & Associates, Inc. PO Box 5199 Clinton,  NJ  08809
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-05-14

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