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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 K781259
Device Name VENTILATION TUBE TEFLON SHEPARD TYPE
Applicant
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Correspondent
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Regulation Number874.3880
Classification Product Code
ETD  
Date Received07/24/1978
Decision Date 08/14/1978
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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