LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER

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 Lo-profile Extensionset W/ .22 Micron Filter.

Pre-market Notification Details

Device IDK925430
510k NumberK925430
Device Name:LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER
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 Received1992-10-27
Decision Date1993-08-03

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