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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 K221477
Device Name AG100s
Applicant
Hospitech Respiration , Ltd.
15 Atir Yeda
Kfar Saba,  IL 446312
Applicant Contact Yoel Bergman
Correspondent
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number868.5750
Classification Product Code
BSK  
Date Received05/23/2022
Decision Date 12/29/2022
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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