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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Powered
510(k) Number K921773
Device Name TX ELECTRIC TOOTHBRUSH
Applicant
Optiva Corp.
2448 76th Ave. SE
Unit 108
Mercer Island,  WA  98040
Applicant Contact STEVE MEGINNISS
Correspondent
Optiva Corp.
2448 76th Ave. SE
Unit 108
Mercer Island,  WA  98040
Correspondent Contact STEVE MEGINNISS
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received04/14/1992
Decision Date 07/13/1992
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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