SOLUTION ADMINISTRATION SET

Set, Administration, Intravascular

DOUGLAS MEDICAL PRODUCTS CORP.

The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for Solution Administration Set.

Pre-market Notification Details

Device IDK921391
510k NumberK921391
Device Name:SOLUTION ADMINISTRATION SET
ClassificationSet, Administration, Intravascular
Applicant DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein,  IL  60060
ContactDouglas Johnson
CorrespondentDouglas Johnson
DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein,  IL  60060
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-23
Decision Date1992-09-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10816415020253 K921391 000

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