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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laryngoscope, rigid
510(k) Number K191602
Device Name APA Oxy Blade
Venner Medical (Singapore) Pte Ltd
35 Joo Koon Circle
Singapore,  SG 629110
Applicant Contact Adrian P. Waterton
Brauer Device Consultants, LLC
7 Trail House Court
Rockville,  MD  20850
Correspondent Contact Christine Brauer
Regulation Number868.5540
Classification Product Code
Subsequent Product Code
Date Received06/17/2019
Decision Date 08/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No