The following data is part of a premarket notification filed by Ahlstrom Dexter with the FDA for Dextex Ii Sterilization Wrap.
Device ID | K800123 |
510k Number | K800123 |
Device Name: | DEXTEX II STERILIZATION WRAP |
Classification | Wrap, Sterilization |
Applicant | AHLSTROM DEXTER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-18 |
Decision Date | 1980-02-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |