Data / Medical devices / United Kingdom / Exmoor Plastics Limited
Exmoor Plastics Limited: FDA-registered device maker in Chorley Lancashire, United Kingdom, 4 510(k) clearances
Exmoor Plastics Limited is registered with the FDA (registration 3002806953) in Chorley Lancashire, United Kingdom. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 5, 1993. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002806953
- Address
- 1 Western Avenue Buckshaw Village, Matrix Park, Chorley Lancashire, United Kingdom, PR7 7NB
- Owner or operator
- Exmoor Plastics Ltd. (10025024)
- Roles
- Manufacturer
- First device listed
- March 10, 2008
- Registered through
- 2027
- Brand names listed
- Bel-Air ventilation tube, Exmoor Aural Specula, Exmoor Aural Ventilation Tubes, Exmoor Nasal Splints, Exmoor Silicone Rubber Sheet, Exmoor Single Use Myringotome, Myringotomy Procedure Pack, Single Use Myringotomy Kits and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Inserter, Myringotomy Tube | JYM | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Manufacturer | accessdata.fda.gov |
| Myringotomy Procedure Kit | OGS | 2 | Manufacturer | accessdata.fda.gov |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | 2 | Manufacturer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tympanostomy | ETD | 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 |
|---|---|---|---|---|---|---|
| May 5, 1993 | K926462 | BEL-AIR VENTILATION TUBE | ETD | Substantially Equivalent | Exmoor Plastics , Ltd. | accessdata.fda.gov |
| February 12, 1993 | K921923 | TITANIUM VENTILATION TUBES | ETD | Substantially Equivalent | Exmoor Plastics , Ltd. | accessdata.fda.gov |
| November 19, 1991 | K911503 | EXMOOR SILICONE RUBBER SHEET | KHJ | Substantially Equivalent | Exmoor Plastics , Ltd. | accessdata.fda.gov |
| September 24, 1991 | K911580 | DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES | ETD | Substantially Equivalent | Exmoor Plastics , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Tympanostomy
- All makers of Inserter, Myringotomy Tube
- All makers of Speculum, Ent
- All makers of Splint, Intranasal Septal
- All makers of Tube, Ear Suction
- All makers of Myringotomy Procedure Kit
Updated May 5, 1993. 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.