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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 K900991
Device Name SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
Applicant
Tocad America, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Applicant Contact JOHN B DUBECK
Correspondent
Tocad America, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Correspondent Contact JOHN B DUBECK
Regulation Number872.6510
Classification Product Code
EFS  
Date Received03/02/1990
Decision Date 05/15/1990
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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