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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
Model 1518000
Device Name MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Original Applicant
MEDTRONIC XOMED
6743 southpoint dr. north
jacksonville,  FL  32216
Original Contact antoine kouchakjy
Regulation Number874.3620
Classification Product Code
NHB  
Date Received08/10/2012
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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