The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for 'exmoor' Single Use Suction Tube.
| Device ID | K892504 |
| 510k Number | K892504 |
| Device Name: | 'EXMOOR' SINGLE USE SUCTION TUBE |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Contact | East, Mcim |
| Correspondent | East, Mcim EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-06-22 |