BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA

Filter, Bacterial, Breathing-circuit

VITAL SIGNS, INC.

The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Bacterial/viral Filter Product Numbers 5100filt, 5100thinm, 5100hepa.

Pre-market Notification Details

Device IDK951047
510k NumberK951047
Device Name:BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
ClassificationFilter, Bacterial, Breathing-circuit
Applicant VITAL SIGNS, INC. 20 CAMPUS RD. Totowa,  NJ  07512
ContactSteve Lieberman
CorrespondentSteve Lieberman
VITAL SIGNS, INC. 20 CAMPUS RD. Totowa,  NJ  07512
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-06
Decision Date1995-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30889483614895 K951047 000

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