CB ERBIUM/2.94(TM) 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 Cb Erbium/2.94(tm) Er:yag Laser.

Pre-market Notification Details

Device IDK970934
510k NumberK970934
Device Name:CB ERBIUM/2.94(TM) 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 Received1997-03-13
Decision Date1997-06-11
Summary:summary

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