HIGH PRESSURE CONNECTING SETS, MODIFICATION

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

E-Z-EM, INC.

The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for High Pressure Connecting Sets, Modification.

Pre-market Notification Details

Device IDK914987
510k NumberK914987
Device Name:HIGH PRESSURE CONNECTING SETS, MODIFICATION
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls,  NY  12801
ContactMerribeth Adams
CorrespondentMerribeth Adams
E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls,  NY  12801
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-24
Decision Date1992-05-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H787123008015 K914987 000

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