ULTRAWAVE II EX 1320

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 Ultrawave Ii Ex 1320.

Pre-market Notification Details

Device IDK070805
510k NumberK070805
Device Name:ULTRAWAVE II EX 1320
ClassificationPowered Laser Surgical Instrument
Applicant QUANTA SYSTEM, S.P.A. 555 THIRTEENTH STREET, NW Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
QUANTA SYSTEM, S.P.A. 555 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-23
Decision Date2007-07-11
Summary:summary

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