ARTHROCARE ENT COBLATOR SURGERY SYSTEM

Electrosurgical, Cutting & Coagulation & Accessories

ARTHROCARE CORP.

The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Ent Coblator Surgery System.

Pre-market Notification Details

Device IDK030108
510k NumberK030108
Device Name:ARTHROCARE ENT COBLATOR SURGERY SYSTEM
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale,  CA  94085 -3523
ContactValerie Defiesta-ng
CorrespondentValerie Defiesta-ng
ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale,  CA  94085 -3523
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-13
Decision Date2003-02-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470002164 K030108 000
00817470001976 K030108 000
00817470001938 K030108 000
00817470001792 K030108 000

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