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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
Applicant
HEMOSTASIS, LLC
5000 township pkwy
saint paul,  MN  55110
Applicant Contact bernard horwath
Correspondent
HEMOSTASIS, LLC
5000 township pkwy
saint paul,  MN  55110
Correspondent 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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