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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K121306
Device Name SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
Applicant
ARTHOCARE CORPORATION
7000 WEST WILLIAM CANNON DRIVE
BUILDING ONE
AUSTIN,  TX  78735
Applicant Contact CHERYL FREDERICK
Correspondent
ARTHOCARE CORPORATION
7000 WEST WILLIAM CANNON DRIVE
BUILDING ONE
AUSTIN,  TX  78735
Correspondent Contact CHERYL FREDERICK
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
NBH  
Date Received05/01/2012
Decision Date 07/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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