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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 K122494
Device Name POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
Original Applicant
HEMOSTASIS, LLC
5000 township pkwy
saint paul,  MN  55110
Original Contact bernard horwath
Regulation Number874.4780
Classification Product Code
LYA  
Subsequent Product Code
EMX  
Date Received08/16/2012
Decision Date 03/27/2013
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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