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 |