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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name polymer, ear, nose and throat, synthetic, absorbable
510(k) Number K161191
Device Name Latera Absorbable Nasal Implant
Applicant
SPIROX, INC.
3475-O EDISON WAY
menlo park,  CA  94025
Applicant Contact mike rosenthal
Correspondent
SPIROX, INC.
3475-O EDISON WAY
menlo park,  CA  94025
Correspondent Contact mike rosenthal
Regulation Number874.3620
Classification Product Code
NHB  
Date Received04/27/2016
Decision Date 06/23/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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