LANCASTER COOLING JACKET, CAT. CODE #13500/13501

Heat-exchanger, Cardiopulmonary Bypass

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Lancaster Cooling Jacket, Cat. Code #13500/13501.

Pre-market Notification Details

Device IDK913077
510k NumberK913077
Device Name:LANCASTER COOLING JACKET, CAT. CODE #13500/13501
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactRoger W Brink
CorrespondentRoger W Brink
DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-11
Decision Date1992-01-09

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