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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name button, nasal septal
510(k) Number K781529
Device Name SEPTAL BUTTON
Applicant
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Correspondent
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Classification Product Code
LFB  
Date Received09/05/1978
Decision Date 10/17/1978
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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