The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Dilkes Laser/suction Cannulae.
| Device ID | K981143 |
| 510k Number | K981143 |
| Device Name: | DILKES LASER/SUCTION CANNULAE |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-30 |
| Decision Date | 1998-09-14 |
| Summary: | summary |