Data / Medical devices / Brazil / Agaplastic Ind. Com. Ltda.
Agaplastic Ind. Com. Ltda.: FDA-registered device maker in Rio De Janeiro, Brazil, 2 510(k) clearances
Agaplastic Ind. Com. Ltda. is registered with the FDA (registration 9615834) in Rio De Janeiro, Brazil. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 29, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615834
- FEI number
- 3003080016
- Address
- Rua Cuba No 353, Rio De Janeiro, Brazil, 21020-160
- Owner or operator
- AGAPLASTIC IND. COM. LTDA. (9040469)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- February 22, 2000
- Registered through
- 2026
- Brand names listed
- AGACHAMBER SPACER, AGACHAMBER SPACER EXTRA, DISPOSITIVO PARA LAVAGEM NASAL PEQUENOS CUIDADOS, Dalmatian Reflex Hammer, NOSE WASH MAX, Nose Wash Syringe, PEDIATRIC ROCKET DOSER, TIC-TONG FLAVORED TONGUE DEPRESSOR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Depressor, Tongue, Non-Surgical | FMA | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Complaint file establishment, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Manufacturer | accessdata.fda.gov |
| Percussor | GWZ | 1 | Complaint file establishment, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Complaint file establishment, Foreign private label distributor, 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 29, 2011 | K101348 | AGACHAMBER SPACER | NVP | Substantially Equivalent | Aga Plastic Ind. Com. Ltda. | accessdata.fda.gov |
| December 9, 1999 | K992995 | AROMATIC AND FLAVORED TONGUE DEPRESSOR | FMA | Substantially Equivalent | Aga Plastic Ind. Com. Ltda. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Ent
- All makers of Depressor, Tongue, Non-Surgical
- All makers of Irrigator, Sinus
- All makers of Nasal Spray, Ent Delivery
- All makers of Dispenser, Liquid Medication
- All makers of Holding Chambers, Direct Patient Interface
Updated April 29, 2011. 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.