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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name splint, intranasal septal
510(k) Number K140992
Device Name ARTHROCARE NASASTENT CMC NASAL DRESSING
Applicant
ARTHROCARE CORPORATION
7000 West William Cannon Drive
Austin,  TX  78735
Applicant Contact MITCHELL DHORITY
Correspondent
ARTHROCARE CORPORATION
7000 West William Cannon Drive
Austin,  TX  78735
Correspondent Contact MITCHELL DHORITY
Regulation Number874.4780
Classification Product Code
LYA  
Date Received04/17/2014
Decision Date 06/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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