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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon, Epistaxis
510(k) Number K220326
Device Name PosiSep X BAM Hemostat Dressing/Intranasal Splint
Applicant
Hemostasis, LLC
5000 Township Pkwy.
St. Paul,  MN  55110
Applicant Contact Lakshmi Ganesh Bollina
Correspondent
Hemostasis, LLC
5000 Township Pkwy.
St. Paul,  MN  55110
Correspondent Contact Lakshmi Ganesh Bollina
Regulation Number874.4100
Classification Product Code
EMX  
Subsequent Product Code
LYA  
Date Received02/04/2022
Decision Date 11/14/2022
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
Predetermined Change
Control Plan Authorized		 No
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