PANASIL INITIAL CONTACT AND PANASIL TRAY

Material, Impression

KETTENBACH GMBH & CO KG

The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Panasil Initial Contact And Panasil Tray.

Pre-market Notification Details

Device IDK083701
510k NumberK083701
Device Name:PANASIL INITIAL CONTACT AND PANASIL TRAY
ClassificationMaterial, Impression
Applicant KETTENBACH GMBH & CO KG 975 VERONICA SPRINGS ROAD Santa Barbara,  CA  93105
ContactKristi Kistner
CorrespondentKristi Kistner
KETTENBACH GMBH & CO KG 975 VERONICA SPRINGS ROAD Santa Barbara,  CA  93105
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-15
Decision Date2009-01-09
Summary:summary

NIH GUDID Devices

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