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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 K230142
Device Name Epi-Stop Nasal Gel/epistaxis pack
Applicant
Biomed Ent, Inc.
18911 Hardy Oak Blvd.
San Antonio,  TX  78258
Applicant Contact Antonius Voermans
Correspondent
Biomed Elements B.V.
Kerkenbos 1077-V
Nijmegen,  NL 6546 BB
Correspondent Contact Marcela Garcia
Regulation Number874.4780
Classification Product Code
LYA  
Date Received01/18/2023
Decision Date 03/22/2023
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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