EVANS SUB-Q, MODEL MC4206

Set, Administration, Intravascular

EVANS MEDICAL, INC.

The following data is part of a premarket notification filed by Evans Medical, Inc. with the FDA for Evans Sub-q, Model Mc4206.

Pre-market Notification Details

Device IDK020530
510k NumberK020530
Device Name:EVANS SUB-Q, MODEL MC4206
ClassificationSet, Administration, Intravascular
Applicant EVANS MEDICAL, INC. P.O. BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
EVANS MEDICAL, INC. P.O. BOX 7007 Deerfield,  IL  60015
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-19
Decision Date2002-04-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817708021325 K020530 000
00817708021264 K020530 000
00817708020588 K020530 000

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