EXACTRAC 5.5

Accelerator, Linear, Medical

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Exactrac 5.5.

Pre-market Notification Details

Device IDK072506
510k NumberK072506
Device Name:EXACTRAC 5.5
ClassificationAccelerator, Linear, Medical
Applicant BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
ContactRainer Birkenbach
CorrespondentRainer Birkenbach
BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-06
Decision Date2007-10-26
Summary:summary

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