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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K143738
Device Name DSS Sinusplasty Balloon Catheter
Applicant
Intuit Medical Products, LLC
6018 Eagles Rest Trail
Sugar Hill,  GA  30518
Applicant Contact Jack Griffis
Correspondent
Intuit Medical Products, LLC
6018 Eagles Rest Trail
Sugar Hill,  GA  30518
Correspondent Contact Jack Griffis
Regulation Number874.4420
Classification Product Code
LRC  
Date Received12/30/2014
Decision Date 08/27/2015
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
Predetermined Change
Control Plan Authorized		 No
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