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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile
510(k) Number K896481
Device Name PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER
Applicant
PUREBRUSH ASSOC.
EDWARD M. BASILE
1730 PENNSYLVANIA AVENUE, N.W.
WASHINGTON,  DC  20006
Applicant Contact & SPALDING
Correspondent
PUREBRUSH ASSOC.
EDWARD M. BASILE
1730 PENNSYLVANIA AVENUE, N.W.
WASHINGTON,  DC  20006
Correspondent Contact & SPALDING
Regulation Number872.6855
Classification Product Code
MCF  
Date Received11/15/1989
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
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