Data / Medical devices / United States / Woodstock Sterile Solutions, Inc.
Woodstock Sterile Solutions, Inc.: FDA-registered device maker in Woodstock, IL, United States, 1 510(k) clearance
Woodstock Sterile Solutions, Inc. is registered with the FDA (registration 3018782623) in Woodstock, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 17, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018782623
- FEI number
- 1419377
- Address
- 2210 Lake Shore Drive, Woodstock, IL, United States, 60098
- Owner or operator
- Woodstock Sterile Solutions, Inc. (10081621)
- Roles
- Repackager or relabeler
- First device listed
- April 30, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 17, 1995 | K935540 | PARI-MASTER MODIFICATION | CAF | Substantially Equivalent | Pari Holding Co. | accessdata.fda.gov |
Compare with other makers
Updated March 17, 1995. 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.