QUANTA SYSTEM ETRNA GIOVINEZZA

Powered Laser Surgical Instrument

QUANTA SYSTEM, S.P.A.

The following data is part of a premarket notification filed by Quanta System, S.p.a. with the FDA for Quanta System Etrna Giovinezza.

Pre-market Notification Details

Device IDK051113
510k NumberK051113
Device Name:QUANTA SYSTEM ETRNA GIOVINEZZA
ClassificationPowered Laser Surgical Instrument
Applicant QUANTA SYSTEM, S.P.A. 10 ELIZABETH DRIVE Chelmsford,  MA  01824
ContactGeorge Cho
CorrespondentGeorge Cho
QUANTA SYSTEM, S.P.A. 10 ELIZABETH DRIVE Chelmsford,  MA  01824
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-02
Decision Date2006-01-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033945934361 K051113 000
08033945934354 K051113 000

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