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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 K052099
FOIA Releasable 510(k) K052099
Device Name NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
Applicant
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN,  NL 9713-GX
Applicant Contact JAN NIEUWENHUIS
Correspondent
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN,  NL 9713-GX
Correspondent Contact JAN NIEUWENHUIS
Regulation Number874.4780
Classification Product Code
LYA  
Date Received08/03/2005
Decision Date 11/21/2005
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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