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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 K871072
Device Name OMEGA NASAL SEPTAL BUTTON
Applicant
OMEGA SILICONE, INC.
725 YANONALI
SANTA BARBARA,  CA  93103
Applicant Contact OLE JOHANSSON
Correspondent
OMEGA SILICONE, INC.
725 YANONALI
SANTA BARBARA,  CA  93103
Correspondent Contact OLE JOHANSSON
Classification Product Code
LFB  
Date Received03/18/1987
Decision Date 06/08/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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