BACTERIAL FILTER

Filter, Bacterial, Breathing-circuit

MED-TEK CORP.

The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for Bacterial Filter.

Pre-market Notification Details

Device IDK894978
510k NumberK894978
Device Name:BACTERIAL FILTER
ClassificationFilter, Bacterial, Breathing-circuit
Applicant MED-TEK CORP. 6685 NORTH SIDNEY PLACE Glendale,  WI  53209
ContactAlan E Whitmarsh
CorrespondentAlan E Whitmarsh
MED-TEK CORP. 6685 NORTH SIDNEY PLACE Glendale,  WI  53209
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-03
Decision Date1989-11-02

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