SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE

Suture, Nonabsorbable, Synthetic, Polyethylene

ARTHOCARE CORPORATION

The following data is part of a premarket notification filed by Arthocare Corporation with the FDA for Smartstitch M-connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle.

Pre-market Notification Details

Device IDK121306
510k NumberK121306
Device Name:SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant ARTHOCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE Austin,  TX  78735
ContactCheryl Frederick
CorrespondentCheryl Frederick
ARTHOCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE Austin,  TX  78735
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-01
Decision Date2012-07-12
Summary:summary

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