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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tympanostomy
510(k) Number K941407
Device Name TYMPANOSTOMY (VENTILATION) TUBE
Applicant
Xomed-Treace, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Applicant Contact ARTHUR A GERTZMAN
Correspondent
Xomed-Treace, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Correspondent Contact ARTHUR A GERTZMAN
Regulation Number874.3880
Classification Product Code
ETD  
Date Received03/23/1994
Decision Date 03/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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