PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER

Filter, Bacterial, Breathing-circuit

SDI DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Pulmoguard Disposable Baterial/viral Filter.

Pre-market Notification Details

Device IDK934509
510k NumberK934509
Device Name:PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER
ClassificationFilter, Bacterial, Breathing-circuit
Applicant SDI DIAGNOSTICS, INC. SHOVEL SHOP SQUARE BUILDING 11 North Easton,  MA  02356
ContactMichael J Boyle
CorrespondentMichael J Boyle
SDI DIAGNOSTICS, INC. SHOVEL SHOP SQUARE BUILDING 11 North Easton,  MA  02356
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-14
Decision Date1993-10-21

NIH GUDID Devices

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