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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Ear, Nose And Throat
510(k) Number K960853
Device Name ACE SYSTEM
Applicant
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact DAVID M TIMLIN
Correspondent
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact DAVID M TIMLIN
Regulation Number874.4140
Classification Product Code
EQJ  
Subsequent Product Code
ERL  
Date Received03/01/1996
Decision Date 04/03/1996
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
Predetermined Change
Control Plan Authorized		 No
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