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510(k) K200968

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R by Insung Medical Co., Ltd. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2020
Date Received
April 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type

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