HOLDER, DENTAL BUR, ALUMINUM

Syringe, Cartridge

MAVERICK SURGICAL, INC.

The following data is part of a premarket notification filed by Maverick Surgical, Inc. with the FDA for Holder, Dental Bur, Aluminum.

Pre-market Notification Details

Device IDK904278
510k NumberK904278
Device Name:HOLDER, DENTAL BUR, ALUMINUM
ClassificationSyringe, Cartridge
Applicant MAVERICK SURGICAL, INC. 16940 - 87 AVENUE Edmonton, Alberta,  CA T5r 4h5
ContactKen Kehoe
CorrespondentKen Kehoe
MAVERICK SURGICAL, INC. 16940 - 87 AVENUE Edmonton, Alberta,  CA T5r 4h5
Product CodeEJI  
CFR Regulation Number872.6770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-17
Decision Date1990-11-02

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