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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 K191858
Device Name Pylant Monitor
Kal-Med LLC
570 Percival Avenue
Kensington,  CT  06037
Applicant Contact Sandra Greenwood
Kal-Med LLC
570 Percival Avenue
Kensington,  CT  06037
Correspondent Contact Sandra Greenwood
Regulation Number868.5750
Classification Product Code
Date Received07/11/2019
Decision Date 02/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No