DERMATECH IV HOLDER

Set, Administration, Intravascular

DERMATECH MEDICAL INC

The following data is part of a premarket notification filed by Dermatech Medical Inc with the FDA for Dermatech Iv Holder.

Pre-market Notification Details

Device IDK060488
510k NumberK060488
Device Name:DERMATECH IV HOLDER
ClassificationSet, Administration, Intravascular
Applicant DERMATECH MEDICAL INC 102 HERITAGE AVE Castle Rock,  CO  80104
ContactGlenn Thibault
CorrespondentGlenn Thibault
DERMATECH MEDICAL INC 102 HERITAGE AVE Castle Rock,  CO  80104
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-24
Decision Date2006-06-08
Summary:summary

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