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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
Applicant
Kal-Med, LLC
570 Percival Ave.
Kensington,  CT  06037
Applicant Contact Sandra Greenwood
Correspondent
Kal-Med, LLC
570 Percival Ave.
Kensington,  CT  06037
Correspondent Contact Sandra Greenwood
Regulation Number868.5750
Classification Product Code
BSK  
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
Predetermined Change
Control Plan Authorized		 No
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