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510(k) K191858

Pylant Monitor by Kal-Med, LLC — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2020
Date Received
July 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

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