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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 K150603
Device Name Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
Applicant
Teleflexmedical, Inc.
2917 Weck Dr.
Durham,  NC  27709
Applicant Contact Lori Pfohl
Correspondent
Teleflexmedical, Inc.
2917 Weck Dr.
Durham,  NC  27709
Correspondent Contact Lori Pfohl
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/10/2015
Decision Date 11/27/2015
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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