STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101

Sterilizer, Steam

SCICAN LTD.

The following data is part of a premarket notification filed by Scican Ltd. with the FDA for Statim 7000 (without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101.

Pre-market Notification Details

Device IDK072466
510k NumberK072466
Device Name:STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
ClassificationSterilizer, Steam
Applicant SCICAN LTD. 1440 DON MILLS RD. Toronto, Ontario,  CA M3b 3p9
ContactTeresa Boyce
CorrespondentTeresa Boyce
SCICAN LTD. 1440 DON MILLS RD. Toronto, Ontario,  CA M3b 3p9
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-04
Decision Date2007-12-19
Summary:summary

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