TAPE, ELASTOPLAST ELASTIC TEAR

Bandage, Elastic

BEIERSDORF, INC.

The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Tape, Elastoplast Elastic Tear.

Pre-market Notification Details

Device IDK781931
510k NumberK781931
Device Name:TAPE, ELASTOPLAST ELASTIC TEAR
ClassificationBandage, Elastic
Applicant BEIERSDORF, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFQM  
CFR Regulation Number880.5075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-11-20
Decision Date1978-12-07

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