SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER

Powered Laser Surgical Instrument

CONTINUUM BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Scanning Device Accessory For Use With The Cb Erbium/2.94 Er:yag Laser.

Pre-market Notification Details

Device IDK971879
510k NumberK971879
Device Name:SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER
ClassificationPowered Laser Surgical Instrument
Applicant CONTINUUM BIOMEDICAL, INC. 6533 SIERRA LN. Dublin,  CA  94568
ContactRobert S Anderson
CorrespondentRobert S Anderson
CONTINUUM BIOMEDICAL, INC. 6533 SIERRA LN. Dublin,  CA  94568
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-21
Decision Date1997-08-14
Summary:summary

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