FIT TEST C&B

Material, Impression

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Fit Test C&b.

Pre-market Notification Details

Device IDK110050
510k NumberK110050
Device Name:FIT TEST C&B
ClassificationMaterial, Impression
Applicant VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
ContactManfred T Plaumann
CorrespondentManfred T Plaumann
VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-07
Decision Date2011-03-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22120951 K110050 000
E22116251 K110050 000

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