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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 K052198
Device Name RELIEVA SINUS BALLOON INFLATION DEVICE
Applicant
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Applicant Contact SU-MIEN CHONG
Correspondent
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Correspondent Contact SU-MIEN CHONG
Regulation Number874.4420
Classification Product Code
LRC  
Date Received08/12/2005
Decision Date 08/31/2005
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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