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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 K131745
Device Name BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
Applicant
Helix Medical, LLC
1110 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact PAUL DRYDEN
Correspondent
Helix Medical, LLC
1110 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact PAUL DRYDEN
Classification Product Code
LFB  
Date Received06/13/2013
Decision Date 09/17/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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