KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662

Dressing, Wound, Drug

TYCO HEALTHCARE

The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Kendall Kerlix Antimicrobial Super Sponge Dressing For Otc Use, Model 6662.

Pre-market Notification Details

Device IDK070653
510k NumberK070653
Device Name:KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
ClassificationDressing, Wound, Drug
Applicant TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactPaul W Evans
CorrespondentPaul W Evans
TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2007-03-09
Decision Date2007-09-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.