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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K240600
Device Name SafeCross Vascular Introducer System (4001)
Applicant
East End Medical I, LLC
10320 Usa Today Way
Miramar,  FL  33025
Applicant Contact David Neugaard
Correspondent
East End Medical I, LLC
10320 Usa Today Way
Miramar,  FL  33025
Correspondent Contact David Neugaard
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/04/2024
Decision Date 09/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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