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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 K904918
Device Name BELSCOPE LARYNGOSCOPE
Applicant
AVULUNGA PTY. LTD.
P.O. BOX 475
MURWILLUMBAH 2484
N.S.W., AUSTRALIA,  AU
Applicant Contact PAUL BELLLHOUSE
Correspondent
AVULUNGA PTY. LTD.
P.O. BOX 475
MURWILLUMBAH 2484
N.S.W., AUSTRALIA,  AU
Correspondent Contact PAUL BELLLHOUSE
Regulation Number868.5540
Classification Product Code
CCW  
Date Received10/31/1990
Decision Date 07/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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