The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Epidrum.
| Device ID | K093863 |
| 510k Number | K093863 |
| Device Name: | EPIDRUM |
| Classification | Syringe, Piston |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Contact | Margaret Blackmore |
| Correspondent | Margaret Blackmore EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-17 |
| Decision Date | 2010-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060180252120 | K093863 | 000 |
| 05060180252113 | K093863 | 000 |
| 05060180254643 | K093863 | 000 |