MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523

Powered Laser Surgical Instrument

HOYA CONBIO, INC

The following data is part of a premarket notification filed by Hoya Conbio, Inc with the FDA for Medlite C Series Compression Tool And Handpiece Attachment Accessory, Model 659-0523.

Pre-market Notification Details

Device IDK060977
510k NumberK060977
Device Name:MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523
ClassificationPowered Laser Surgical Instrument
Applicant HOYA CONBIO, INC 47733 FREMONT BLVD Fremont,  CA  94538
ContactJim Green
CorrespondentJim Green
HOYA CONBIO, INC 47733 FREMONT BLVD Fremont,  CA  94538
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-10
Decision Date2006-05-24
Summary:summary

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