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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K031681
Device Name STERISIL ANTIMICROBIAL TUBING AND BOTTLE
Applicant
Sterisil
200 S. Wilcox
Castle Rock,  CO  80104
Applicant Contact BRAD DOWNS
Correspondent
Sterisil
200 S. Wilcox
Castle Rock,  CO  80104
Correspondent Contact BRAD DOWNS
Regulation Number872.6640
Classification Product Code
EIA  
Date Received05/30/2003
Decision Date 10/30/2003
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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