STERISIL ANTIMICROBIAL TUBING AND BOTTLE

Unit, Operative Dental

STERISIL

The following data is part of a premarket notification filed by Sterisil with the FDA for Sterisil Antimicrobial Tubing And Bottle.

Pre-market Notification Details

Device IDK031681
510k NumberK031681
Device Name:STERISIL ANTIMICROBIAL TUBING AND BOTTLE
ClassificationUnit, Operative Dental
Applicant STERISIL 200 S. WILCOX Castle Rock,  CO  80104
ContactBrad Downs
CorrespondentBrad Downs
STERISIL 200 S. WILCOX Castle Rock,  CO  80104
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2003-05-30
Decision Date2003-10-30

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