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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K202874
Device Name Puritan Bennett Cuff Pressure Manager
Applicant
Covidien, LLC
6f, Bldg. 3, 2388 Chenhang Rd.
Shanghai,  CN 201114
Applicant Contact Jenny Liu
Correspondent
Covidien, LLC
6f, Bldg. 3, 2388 Chenhang Rd.
Shanghai,  CN 201114
Correspondent Contact Jenny Liu
Regulation Number868.5750
Classification Product Code
BSK  
Date Received09/28/2020
Decision Date 01/09/2021
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
Recalls CDRH Recalls
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