COOLAN 300

Powered Laser Surgical Instrument

COOLANALGESIA LTD.

The following data is part of a premarket notification filed by Coolanalgesia Ltd. with the FDA for Coolan 300.

Pre-market Notification Details

Device IDK030810
510k NumberK030810
Device Name:COOLAN 300
ClassificationPowered Laser Surgical Instrument
Applicant COOLANALGESIA LTD. WILLIAM GATES BUILDING 15 J.J. THOMSON AVENUE Cambridge, England,  GB Cb3 0fd
ContactPeter Wilkinson
CorrespondentPamela Gwynn
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-03-13
Decision Date2004-05-05

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