FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL

Material, Impression

HERAEUS KULZER, LLC

The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge Refill.

Pre-market Notification Details

Device IDK101617
510k NumberK101617
Device Name:FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
ClassificationMaterial, Impression
Applicant HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend,  IN  46614
ContactCheryl Zimmerman
CorrespondentCheryl Zimmerman
HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend,  IN  46614
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-09
Decision Date2010-09-07
Summary:summary

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