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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name splint, intranasal septal
510(k) Number K141423
Device Name NASOPORE-FD
Applicant
Polyganics BV
ROZENBURGLAAN 15A
GRONINGEN,  NL 9727-DL
Applicant Contact BETTY IJMKER
Correspondent
Polyganics BV
ROZENBURGLAAN 15A
GRONINGEN,  NL 9727-DL
Correspondent Contact BETTY IJMKER
Regulation Number874.4780
Classification Product Code
LYA  
Date Received05/30/2014
Decision Date 08/07/2014
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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