DISPOSABLE BACTERIAL BREATHNG FILTER

Filter, Bacterial, Breathing-circuit

HOSPITAK, INC.

The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Disposable Bacterial Breathng Filter.

Pre-market Notification Details

Device IDK915750
510k NumberK915750
Device Name:DISPOSABLE BACTERIAL BREATHNG FILTER
ClassificationFilter, Bacterial, Breathing-circuit
Applicant HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst,  NY  11757
ContactWilliam J Lacey
CorrespondentWilliam J Lacey
HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst,  NY  11757
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-19
Decision Date1994-11-30

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