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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 K111254
Device Name RELIEVA SOLO ELITE SINUS BALLOON CATHETER
Applicant
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Applicant Contact KIM KY
Correspondent
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Correspondent Contact KIM KY
Regulation Number874.4420
Classification Product Code
LRC  
Date Received05/04/2011
Decision Date 08/22/2011
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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