CHECK VALVE SOLUTION 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 Check Valve Solution Set.

Pre-market Notification Details

Device IDK941453
510k NumberK941453
Device Name:CHECK VALVE SOLUTION 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 Received1994-03-25
Decision Date1994-08-16

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