Aspire Mechanical Aspirator G

Syringe, Piston

Control Medical Technology

The following data is part of a premarket notification filed by Control Medical Technology with the FDA for Aspire Mechanical Aspirator G.

Pre-market Notification Details

Device IDK200629
510k NumberK200629
Device Name:Aspire Mechanical Aspirator G
ClassificationSyringe, Piston
Applicant Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City,  UT  84115
ContactShawn Fojtik
CorrespondentShawn Fojtik
Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City,  UT  84115
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-10
Decision Date2020-05-29

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