ASPEN ESMARK BANDAGE

Bandage, Elastic

ASPEN LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK872868
510k NumberK872868
Device Name:ASPEN ESMARK BANDAGE
ClassificationBandage, Elastic
Applicant ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood,  CO  80155 -3936
ContactJohnson
CorrespondentJohnson
ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood,  CO  80155 -3936
Product CodeFQM  
CFR Regulation Number880.5075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-21
Decision Date1987-07-31

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