PRESSURE SENSING SYRINGE 65000

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Pressure Sensing Syringe 65000.

Pre-market Notification Details

Device IDK853586
510k NumberK853586
Device Name:PRESSURE SENSING SYRINGE 65000
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactRonald A Williams
CorrespondentRonald A Williams
DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-26
Decision Date1985-11-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994918530 K853586 000
20613994918493 K853586 000

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