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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 K984069
Device Name ENTAXIS NASAL PACKING
Applicant
LES LABORATORIRES BROTHIER, S.A.
7527 WESTMORELAND AVE.
ST LOUIS,  MO  63105
Applicant Contact EVAN DICK
Correspondent
LES LABORATORIRES BROTHIER, S.A.
7527 WESTMORELAND AVE.
ST LOUIS,  MO  63105
Correspondent Contact EVAN DICK
Regulation Number874.4100
Classification Product Code
EMX  
Date Received11/16/1998
Decision Date 01/25/1999
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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