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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 K140951
Device Name YEESCOPE LARYNGOSCOPES
Applicant
YEESCOPE PTY. LTD.
10 BINNEY ROAD
KINGS PARK, NSW,  AU 2148
Applicant Contact PAUL DRYDEN
Correspondent
YEESCOPE PTY. LTD.
10 BINNEY ROAD
KINGS PARK, NSW,  AU 2148
Correspondent Contact PAUL DRYDEN
Regulation Number868.5540
Classification Product Code
CCW  
Date Received04/14/2014
Decision Date 11/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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