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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Bite Block
510(k) Number K914978
Device Name OXYGUARD
Applicant
Stantex Pty , Ltd.
144 Great N. Rd., Five Dock
Sydney, New South Wales,  AU 2046
Applicant Contact THOMAS J BORODY
Correspondent
Stantex Pty , Ltd.
144 Great N. Rd., Five Dock
Sydney, New South Wales,  AU 2046
Correspondent Contact THOMAS J BORODY
Regulation Number876.1500
Classification Product Code
MNK  
Date Received11/06/1991
Decision Date 01/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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