Data / Medical devices / United States / Sylvan Corp.
Sylvan Corp.: FDA-registered device maker in Irwin, PA, United States, 1 510(k) clearance
Sylvan Corp. is registered with the FDA (registration 2529322) in Irwin, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 24, 1990. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2529322
- FEI number
- 1000121549
- Address
- 612 Cedar St., Irwin, PA, United States, 15642
- Owner or operator
- SYLVAN CORP. (9000618)
- Roles
- Manufacturer
- First device listed
- April 15, 2008
- Registered through
- 2026
- Brand names listed
- MAXISCAN, PEDIASCAN, Maxiscan, Pediascan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transilluminator, Battery-Powered | HJN | 1 | 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 |
|---|---|---|---|---|---|---|
| May 24, 1990 | K901309 | SYLVAN PEDIASCAN 200 TRANSILLUMINATOR | HJN | Substantially Equivalent | Sylvan Corp. | accessdata.fda.gov |
Compare with other makers
Updated May 24, 1990. 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.