COMFEEL POWDER

Beads, Hydrophilic, For Wound Exudate Absorption

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel Powder.

Pre-market Notification Details

Device IDK834343
510k NumberK834343
Device Name:COMFEEL POWDER
ClassificationBeads, Hydrophilic, For Wound Exudate Absorption
Applicant COLOPLAST A/S 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKOZ  
CFR Regulation Number878.4018 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-12
Decision Date1984-11-08

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