DEXTEX II STERILIZATION WRAP

Wrap, Sterilization

AHLSTROM DEXTER

The following data is part of a premarket notification filed by Ahlstrom Dexter with the FDA for Dextex Ii Sterilization Wrap.

Pre-market Notification Details

Device IDK800123
510k NumberK800123
Device Name:DEXTEX II STERILIZATION WRAP
ClassificationWrap, Sterilization
Applicant AHLSTROM DEXTER 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-01-18
Decision Date1980-02-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889950035426 K800123 000
10889950002824 K800123 000
10889950002817 K800123 000
10889950002794 K800123 000
10889950002787 K800123 000
10889950002763 K800123 000
10889950002756 K800123 000
10889950002732 K800123 000
10889950002725 K800123 000
10889950002831 K800123 000
10889950002848 K800123 000
10889950035419 K800123 000
10889950035402 K800123 000
10889950002909 K800123 000
10889950002893 K800123 000
10889950002886 K800123 000
10889950002879 K800123 000
10889950002862 K800123 000
10889950002855 K800123 000
10889950134112 K800123 000

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