MODIFICATION TO ARTHROCARE ARTHROWANDS

Electrosurgical, Cutting & Coagulation & Accessories

ARTHROCARE CORP.

The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Modification To Arthrocare Arthrowands.

Pre-market Notification Details

Device IDK083306
510k NumberK083306
Device Name:MODIFICATION TO ARTHROCARE ARTHROWANDS
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 Received2008-11-10
Decision Date2008-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470006551 K083306 000
00817470006506 K083306 000
00817470004908 K083306 000
00817470003017 K083306 000
00817470003000 K083306 000
00817470001761 K083306 000
00817470000436 K083306 000
00817470000016 K083306 000

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