CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS

Powered Laser Surgical Instrument

CLINICON CORP.

The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Clinicon Universal Waveguide Handpiece And Fiber Tips.

Pre-market Notification Details

Device IDK014048
510k NumberK014048
Device Name:CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS
ClassificationPowered Laser Surgical Instrument
Applicant CLINICON CORP. 16787 BERNARDO CENTER DR. SUITE A San Diego,  CA  92128
ContactSean M Curry
CorrespondentSean M Curry
CLINICON CORP. 16787 BERNARDO CENTER DR. SUITE A San Diego,  CA  92128
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-07
Decision Date2002-02-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850013050123 K014048 000
00850013050017 K014048 000
00850013050024 K014048 000
00850013050031 K014048 000
00850013050048 K014048 000
00850013050055 K014048 000
00850013050062 K014048 000
00850013050079 K014048 000
00850013050086 K014048 000
00850013050093 K014048 000
00850013050116 K014048 000
00850013050000 K014048 000

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