STAT IM 5000 CASSETTE AUTOCLAVE

Sterilizer, Steam

SCICAN

The following data is part of a premarket notification filed by Scican with the FDA for Stat Im 5000 Cassette Autoclave.

Pre-market Notification Details

Device IDK962179
510k NumberK962179
Device Name:STAT IM 5000 CASSETTE AUTOCLAVE
ClassificationSterilizer, Steam
Applicant SCICAN 2002 SMALLMAN ST. Pittsburgh,  PA  15222
ContactNeil Mcphail
CorrespondentNeil Mcphail
SCICAN 2002 SMALLMAN ST. Pittsburgh,  PA  15222
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-06
Decision Date1997-01-13
Summary:summary

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