AIRPREP SYSTEM - MODEL 9001

Airbrush

ASI MEDICAL, INC.

The following data is part of a premarket notification filed by Asi Medical, Inc. with the FDA for Airprep System - Model 9001.

Pre-market Notification Details

Device IDK974488
510k NumberK974488
Device Name:AIRPREP SYSTEM - MODEL 9001
ClassificationAirbrush
Applicant ASI MEDICAL, INC. 14550 EAST EASTER AVE. SUITE 700 Englewood,  CO  80112
ContactJohn W Mcpeek
CorrespondentJohn W Mcpeek
ASI MEDICAL, INC. 14550 EAST EASTER AVE. SUITE 700 Englewood,  CO  80112
Product CodeKOJ  
CFR Regulation Number872.6080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-26
Decision Date1998-05-26

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