Provicol QM Plus

Zinc Oxide Eugenol

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Provicol Qm Plus.

Pre-market Notification Details

Device IDK161630
510k NumberK161630
Device Name:Provicol QM Plus
ClassificationZinc Oxide Eugenol
Applicant VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven,  DE 27472
ContactTh. Plaumann
CorrespondentT. Gerkensmeier
VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven,  DE 27472
Product CodeEMB  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-13
Decision Date2016-09-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22110981 K161630 000

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