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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 K141816
Device Name HEMOPORE
Applicant
Polyganics BV
ROZENBURGLAAN 15A
GRONINGEN,  NL 9727DL
Applicant Contact BETTY IJMKER
Correspondent
Polyganics BV
ROZENBURGLAAN 15A
GRONINGEN,  NL 9727DL
Correspondent Contact BETTY IJMKER
Regulation Number874.4780
Classification Product Code
LYA  
Date Received07/07/2014
Decision Date 10/23/2014
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
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