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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K230778
Device Name EndoCore
Applicant
Praxis Medical, LLC
500 N Willow Ave. Suite 101
Tampa,  FL  33606
Applicant Contact John Fisher
Correspondent
Praxis Medical, LLC C/O Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number874.4680
Classification Product Code
KTI  
Date Received03/21/2023
Decision Date 09/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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