MICROPOWER HAND PIECE HIGH SPEED DRILL

Motor, Drill, Electric

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Micropower Hand Piece High Speed Drill.

Pre-market Notification Details

Device IDK060260
510k NumberK060260
Device Name:MICROPOWER HAND PIECE HIGH SPEED DRILL
ClassificationMotor, Drill, Electric
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactElizabeth Paul
CorrespondentElizabeth Paul
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeHBC  
CFR Regulation Number882.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-01
Decision Date2006-04-10
Summary:summary

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