C4

Powered Laser Surgical Instrument

CLINICON CORP.

The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for C4.

Pre-market Notification Details

Device IDK970143
510k NumberK970143
Device Name:C4
ClassificationPowered Laser Surgical Instrument
Applicant CLINICON CORP. 2260 RUTHERFORD RD., #101 Carlsbad,  CA  92008
ContactAlan Bunting
CorrespondentAlan Bunting
CLINICON CORP. 2260 RUTHERFORD RD., #101 Carlsbad,  CA  92008
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-15
Decision Date1997-10-29
Summary:summary

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