INTEGRA LED SURGICAL HEADLIGHT SYSTEM

Light, Headband, Surgical

INTEGRA LIFE SCIENCES CORPORATION

The following data is part of a premarket notification filed by Integra Life Sciences Corporation with the FDA for Integra Led Surgical Headlight System.

Pre-market Notification Details

Device IDK110528
510k NumberK110528
Device Name:INTEGRA LED SURGICAL HEADLIGHT SYSTEM
ClassificationLight, Headband, Surgical
Applicant INTEGRA LIFE SCIENCES CORPORATION 589 DAVIES DRIVE York,  PA  17402
ContactStephanie Sheesley
CorrespondentStephanie Sheesley
INTEGRA LIFE SCIENCES CORPORATION 589 DAVIES DRIVE York,  PA  17402
Product CodeFSR  
CFR Regulation Number886.4335 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-24
Decision Date2011-05-11
Summary:summary

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