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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
Predetermined Change
Control Plan Authorized		 No
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