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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K241451
Device Name Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
Applicant
Teleflex Incorporated
3015 Carrington Mills Blvd.
Suite 600
Morrisville,  NC  27560
Applicant Contact Bouse Angela
Correspondent
Teleflex Incorporated
3015 Carrington Mills Blvd.
Suite 600
Morrisville,  NC  27560
Correspondent Contact Bouse Angela
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/22/2024
Decision Date 02/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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