MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH

Handpiece, Contra- And Right-angle Attachment, Dental

HANDPIECE HEADQUARTERS

The following data is part of a premarket notification filed by Handpiece Headquarters with the FDA for Maxima-m Straight Attachment, Maxima-m Contra Angle Sheath.

Pre-market Notification Details

Device IDK092053
510k NumberK092053
Device Name:MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH
ClassificationHandpiece, Contra- And Right-angle Attachment, Dental
Applicant HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia,  CA  92870
ContactTim Ropchan
CorrespondentTim Ropchan
HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia,  CA  92870
Product CodeEGS  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-07
Decision Date2009-08-20
Summary:summary

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