Data / Medical devices / United States / Ahlstrom Nonwovens LLC
Ahlstrom Nonwovens LLC: FDA-registered device maker in Windsor Locks, CT, United States, 4 510(k) clearances
Ahlstrom Nonwovens LLC is registered with the FDA (registration 1217231) in Windsor Locks, CT, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated December 7, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1217231
- Address
- 3 Chirnside Rd, Windsor Locks, CT, United States, 06096
- Owner or operator
- AHLSTROM NONWOVENS LLC (1218934)
- Roles
- Manufacturer
- First device listed
- November 7, 2007
- Registered through
- 2026
- Brand names listed
- DEXTEX, Dextex 100, Dextex 200, Dextex ECO, ECONOMY, ECONOMY PLUS, HEAVY DUTY, OptiWrap A100 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wrap, Sterilization | FRG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 7, 2023 | K230137 | Reliance® Fusion Sterilization Wraps | FRG | Substantially Equivalent | Ahlstrom-Munksjo Nonwovens, LLC | accessdata.fda.gov |
| July 27, 2016 | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | FRG | Substantially Equivalent | Ahlstrom Nonwovens, LLC | accessdata.fda.gov |
| August 15, 1989 | K893764 | STERILIZATION TRAY LINER | FRG | Substantially Equivalent | Ahlstrom Dexter | accessdata.fda.gov |
| February 13, 1980 | K800123 | DEXTEX II STERILIZATION WRAP | FRG | Substantially Equivalent | Ahlstrom Dexter | accessdata.fda.gov |
Compare with other makers
Updated December 7, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.