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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 K141704
Device Name NOVASHIELD INJECTABLE NASAL PACKING AND STENT
Applicant
MEDTRONIC INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32259
Applicant Contact RISHI SINHA
Correspondent
MEDTRONIC INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32259
Correspondent Contact RISHI SINHA
Regulation Number874.4780
Classification Product Code
LYA  
Date Received06/24/2014
Decision Date 10/06/2014
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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