Data / Medical devices / Israel / Stepac L.a., Ltd.
Stepac L.a., Ltd.: FDA-registered device maker in TEFEN, WESTERN GALILEE Northern, Israel, 1 510(k) clearance
Stepac L.a., Ltd. is registered with the FDA (registration 9680031) in TEFEN, WESTERN GALILEE Northern, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 23, 1987. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680031
- FEI number
- 1000199482
- Address
- Tefen Industrial Park BLDG No. 12, TEFEN, WESTERN GALILEE Northern, Israel, 24959
- Owner or operator
- Stepac L.A., Ltd. (9006511)
- Roles
- Manufacturer
- First device listed
- February 12, 2008
- Registered through
- 2026
- Brand names listed
- Nylon Sterilization Film
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 |
|---|---|---|---|---|---|---|
| April 23, 1987 | K870147 | CARERITE & COST RITE NYLON STERILIZATION FILM | FRG | Substantially Equivalent | Cost Rite Health Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 23, 1987. 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.