ENDOBEAM HOLMIUM LASER FIBERS

Powered Laser Surgical Instrument

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Endobeam Holmium Laser Fibers.

Pre-market Notification Details

Device IDK120926
510k NumberK120926
Device Name:ENDOBEAM HOLMIUM LASER FIBERS
ClassificationPowered Laser Surgical Instrument
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington,  GA  30209
ContactTerri Morris
CorrespondentTerri Morris
C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington,  GA  30209
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-27
Decision Date2012-07-27
Summary:summary

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