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FDA 510(k) Application Details - K221477
Device Classification Name
Cuff, Tracheal Tube, Inflatable
More FDA Info for this Device
510(K) Number
K221477
Device Name
Cuff, Tracheal Tube, Inflatable
Applicant
Hospitech Respiration Ltd.
15 Atir Yeda
Kfar Saba 446312 IL
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Contact
Yoel Bergman
Other 510(k) Applications for this Contact
Regulation Number
868.5750
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Classification Product Code
BSK
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More FDA Info for this Product Code
Date Received
05/23/2022
Decision Date
12/29/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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