Data / Medical devices / Costa Rica / Laboratorios Zepol S.A.
Laboratorios Zepol S.A.: FDA-registered device maker in Curridabat San Jose, Costa Rica, 2 510(k) clearances
Laboratorios Zepol S.A. is registered with the FDA (registration 3004637474) in Curridabat San Jose, Costa Rica. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 20, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004637474
- Address
- 75 Mts Al Norte Del Servicentro La Galera Carretera a Cipreses, Curridabat San Jose, Costa Rica, 3399-1000
- Owner or operator
- Laboratorios Zepol S.A. (10055427)
- Roles
- Manufacturer
- First device listed
- July 24, 2017
- Registered through
- 2026
- Brand names listed
- Asclepii Poseidon Nanosilver Hydrogel OTC 1oz, Asclepii Poseidon Nanosilver Hydrogel OTC 3oz, Asclepii Poseidon Nanosilver Hydrogel Rx 1 oz, Asclepii Poseidon Nanosilver Hydrogel Rx 3 oz
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | 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 20, 2017 | K162017 | Ross Ru Wound Dressing Gel | FRO | Substantially Equivalent | Biotd S.A. | accessdata.fda.gov |
| May 12, 2014 | K131176 | ROSS RU SKIN DISCONTINUITIES | FRO | Substantially Equivalent | Biotd S.A. | accessdata.fda.gov |
Compare with other makers
Updated April 20, 2017. 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.