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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tent, Oxygen
510(k) Number K905627
Device Name NASCOR OXYDOME
Applicant
Nascor Pty. , Ltd.
7 Watson Rd.
Padstow, N.Sw2211
Sydney, Australia,  AU
Applicant Contact HOWARD CHILTON
Correspondent
Nascor Pty. , Ltd.
7 Watson Rd.
Padstow, N.Sw2211
Sydney, Australia,  AU
Correspondent Contact HOWARD CHILTON
Regulation Number868.5700
Classification Product Code
BYL  
Date Received12/14/1990
Decision Date 06/03/1991
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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