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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 K890600
Device Name HYDRODENT ANTIPLAQUE SYSTEM
Applicant
Hydrodent Laboratories, Inc.
Suite 1901
801 Brickell Ave.
Miami,  FL  33131
Applicant Contact JOEL BERNSTEIN
Correspondent
Hydrodent Laboratories, Inc.
Suite 1901
801 Brickell Ave.
Miami,  FL  33131
Correspondent Contact JOEL BERNSTEIN
Regulation Number872.6510
Classification Product Code
EFS  
Date Received02/06/1989
Decision Date 05/05/1989
Decision Substantially Equivalent - With Drug (SESD)
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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