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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Nasal
510(k) Number K791681
Device Name THE DENVER SPLINT
Applicant
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Correspondent
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Regulation Number874.5800
Classification Product Code
EPP  
Date Received08/28/1979
Decision Date 10/22/1979
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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