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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 K871200
Device Name CUI NASAL SEPTUM BUTTON
Applicant
Cox-Uphuff Intl.
1160 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact DAVID J SCHUESSLER
Correspondent
Cox-Uphuff Intl.
1160 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact DAVID J SCHUESSLER
Classification Product Code
LFB  
Date Received03/25/1987
Decision Date 04/15/1987
Decision Substantially Equivalent (SESE)
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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