BIOSYAG MEDICAL SYSTEM

Powered Laser Surgical Instrument

BIOS S.R.L.

The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Biosyag Medical System.

Pre-market Notification Details

Device IDK080374
510k NumberK080374
Device Name:BIOSYAG MEDICAL SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant BIOS S.R.L. 4235 E. BROADWAY Long Beach,  CA  90803
ContactAlessandro Franchi
CorrespondentAlessandro Franchi
BIOS S.R.L. 4235 E. BROADWAY Long Beach,  CA  90803
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-12
Decision Date2008-05-15
Summary:summary

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