MDT/CASTLE 10/90 LOAD STATION

Sterilizer, Ethylene-oxide Gas

MDT BIOLOGIC CO.

The following data is part of a premarket notification filed by Mdt Biologic Co. with the FDA for Mdt/castle 10/90 Load Station.

Pre-market Notification Details

Device IDK910649
510k NumberK910649
Device Name:MDT/CASTLE 10/90 LOAD STATION
ClassificationSterilizer, Ethylene-oxide Gas
Applicant MDT BIOLOGIC CO. 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester,  NY  14692
ContactMark N Smith
CorrespondentMark N Smith
MDT BIOLOGIC CO. 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester,  NY  14692
Product CodeFLF  
CFR Regulation Number880.6860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-14
Decision Date1991-09-06

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