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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 K202623
Device Name Novapak Nasal Sinus Packing and Stent
Applicant
Medtronic Xomed
6743 Southpoint Drive North
Jacksonville,  FL  32256
Applicant Contact Matthew Harmon
Correspondent
Medtronic Xomed
6743 Southpoint Drive North
Jacksonville,  FL  32256
Correspondent Contact Matthew Harmon
Regulation Number874.4780
Classification Product Code
LYA  
Date Received09/10/2020
Decision Date 12/08/2020
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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