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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 K122434
Device Name MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Applicant
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Applicant Contact ANTOINE KOUCHAKJY
Correspondent
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Correspondent Contact ANTOINE KOUCHAKJY
Regulation Number874.3620
Classification Product Code
NHB  
Date Received08/10/2012
Decision Date 10/31/2012
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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