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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K894933
Device Name PERLIDENT
Applicant
Germiphene Corp.
P.O. Box 1748
Brantford Ontario,  CA N3T 5V7
Applicant Contact ALAN SCHWARTZ
Correspondent
Germiphene Corp.
P.O. Box 1748
Brantford Ontario,  CA N3T 5V7
Correspondent Contact ALAN SCHWARTZ
Regulation Number872.6030
Classification Product Code
EJR  
Date Received08/03/1989
Decision Date 10/12/1989
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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