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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 K061903
Device Name RELIEVA SINUS BALLOON CATHETER
Applicant
Acclarent, Inc.
1525-B O'Brien Dr.
Rmenlo Park,  CA  94025
Applicant Contact KERI YEN
Correspondent
Acclarent, Inc.
1525-B O'Brien Dr.
Rmenlo Park,  CA  94025
Correspondent Contact KERI YEN
Regulation Number874.4420
Classification Product Code
LRC  
Date Received07/05/2006
Decision Date 08/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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