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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer, ear, nose and throat, synthetic, absorbable
510(k) Number K210411
Device Name PosiSep EAR Fragmentable Ear Dressing
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 Number874.3620
Classification Product Code
NHB  
Date Received02/11/2021
Decision Date 05/05/2022
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
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