POWERLED SURGICAL LIGHT SYSTEM

Light, Surgical, Ceiling Mounted

MAQUET S.A.

The following data is part of a premarket notification filed by Maquet S.a. with the FDA for Powerled Surgical Light System.

Pre-market Notification Details

Device IDK070442
510k NumberK070442
Device Name:POWERLED SURGICAL LIGHT SYSTEM
ClassificationLight, Surgical, Ceiling Mounted
Applicant MAQUET S.A. 1777 EAST HENRIETTA RD. Rochester,  NY  14623
ContactKevin M Tompkins
CorrespondentKevin M Tompkins
MAQUET S.A. 1777 EAST HENRIETTA RD. Rochester,  NY  14623
Product CodeFSY  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-15
Decision Date2007-03-16
Summary:summary

NIH GUDID Devices

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