PAL Multi-Use Cannulas And PAL Manual Wand

System, Suction, Lipoplasty

MicroAire Surgical Instruments, LLC

The following data is part of a premarket notification filed by Microaire Surgical Instruments, Llc with the FDA for Pal Multi-use Cannulas And Pal Manual Wand.

Pre-market Notification Details

Device IDK171286
510k NumberK171286
Device Name:PAL Multi-Use Cannulas And PAL Manual Wand
ClassificationSystem, Suction, Lipoplasty
Applicant MicroAire Surgical Instruments, LLC 3590 Grans Forks Blvd Charlottesville,  VA  22911
ContactGlenn Gerstenfeld
CorrespondentDiane Sudduth
BARILE & ASSOCIATES, INC P.O. Box 5199 Clinton,  NJ  08809
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-01
Decision Date2017-10-13
Summary:summary

NIH GUDID Devices

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