ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS

Powered Laser Surgical Instrument

ALTUS MEDICAL, INC.

The following data is part of a premarket notification filed by Altus Medical, Inc. with the FDA for Altus Medical Family Of Coolglide Lasers, Models Coolglide I, Coolglide Ii, And Future Models.

Pre-market Notification Details

Device IDK022226
510k NumberK022226
Device Name:ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS
ClassificationPowered Laser Surgical Instrument
Applicant ALTUS MEDICAL, INC. 821 COWAN RD. Burlingame,  CA  94010
ContactKathy Maynor
CorrespondentKathy Maynor
ALTUS MEDICAL, INC. 821 COWAN RD. Burlingame,  CA  94010
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-10
Decision Date2002-10-08
Summary:summary

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