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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 K132920
Device Name SPIROX INEX DEVICE
Applicant
Spirox, Inc.
381 Arlington Way
Menlo Park,  CA  94025
Applicant Contact MIKE ROSENTHAL
Correspondent
Spirox, Inc.
381 Arlington Way
Menlo Park,  CA  94025
Correspondent Contact MIKE ROSENTHAL
Regulation Number874.3620
Classification Product Code
NHB  
Date Received09/17/2013
Decision Date 06/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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