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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Sinus
510(k) Number K813474
Device Name MAXILL-AIR SINUS VENTILATION TUBE
Applicant
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Correspondent
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Regulation Number878.4800
Classification Product Code
KAM  
Date Received12/01/1981
Decision Date 01/12/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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