SILASTIC SOFT SHEETING

Dressing, Wound, Drug

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Silastic Soft Sheeting.

Pre-market Notification Details

Device IDK894226
510k NumberK894226
Device Name:SILASTIC SOFT SHEETING
ClassificationDressing, Wound, Drug
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactMicki Roy
CorrespondentMicki Roy
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-19
Decision Date1990-01-03

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