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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Oral Irrigation
510(k) Number K910832
Device Name OXYFRESH OXYCARE 3000
Applicant
Oxyfresh
P.O. Box 3723
Spokane,  WA  99220
Applicant Contact VERNON A NORD
Correspondent
Oxyfresh
P.O. Box 3723
Spokane,  WA  99220
Correspondent Contact VERNON A NORD
Regulation Number872.6510
Classification Product Code
EFS  
Date Received02/27/1991
Decision Date 04/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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