HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT

Handpiece, Air-powered, Dental

HANDPIECE HEADQUARTERS

The following data is part of a premarket notification filed by Handpiece Headquarters with the FDA for Hhc Push-button Replacement Turbine For Midwest Tradition Handpiece Model Mw Turbine Replacement.

Pre-market Notification Details

Device IDK100389
510k NumberK100389
Device Name:HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
ClassificationHandpiece, Air-powered, Dental
Applicant HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia,  CA  92870
ContactTina Steffaine-oak
CorrespondentTina Steffaine-oak
HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia,  CA  92870
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-16
Decision Date2010-08-12
Summary:summary

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