POLYMER ADHESIVE BANDAGE

Dressing, Wound, Drug

MARION LABORATORIES, INC.

The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Polymer Adhesive Bandage.

Pre-market Notification Details

Device IDK883391
510k NumberK883391
Device Name:POLYMER ADHESIVE BANDAGE
ClassificationDressing, Wound, Drug
Applicant MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City,  MI  64134
ContactM Mondabaugh
CorrespondentM Mondabaugh
MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City,  MI  64134
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-09
Decision Date1989-03-23

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