The following data is part of a premarket notification filed by Keymed (medical And Industrial Equipment) Ltd. with the FDA for Irrigation Tubing With Co2 Or Air.
| Device ID | K193250 |
| 510k Number | K193250 |
| Device Name: | Irrigation Tubing With CO2 Or Air |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | KeyMed (Medical And Industrial Equipment) Ltd. KeyMed House, Stock Road Southend-on-sea, GB Ss2 5qh |
| Contact | Andy Hollingsworth |
| Correspondent | Mary Anne Patella Olympus Surgical Tech America - Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2020-04-06 |