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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name balloon, epistaxis
510(k) Number K982731
Device Name MEROGEL NASAL DRESSING AND SINUS STENT
Applicant
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact ROY BERENS
Correspondent
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact ROY BERENS
Regulation Number874.4100
Classification Product Code
EMX  
Date Received08/05/1998
Decision Date 02/02/1999
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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