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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Manual
510(k) Number K992435
Device Name BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
Applicant
Azo Enterprises
6114 N. Sacramento
Chicago,  IL  60659
Applicant Contact NABIL AZO
Correspondent
Azo Enterprises
6114 N. Sacramento
Chicago,  IL  60659
Correspondent Contact NABIL AZO
Regulation Number872.6855
Classification Product Code
EFW  
Date Received07/22/1999
Decision Date 10/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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