The following data is part of a premarket notification filed by Clyra Medical Technologies Inc. with the FDA for Clyra Wound Irrigation Solution.
| Device ID | K181428 |
| 510k Number | K181428 |
| Device Name: | Clyra Wound Irrigation Solution |
| Classification | Dressing, Wound, Drug |
| Applicant | Clyra Medical Technologies Inc. 14921 Chestnut St. Westminster, CA 92683 |
| Contact | Steven V. Harrison |
| Correspondent | Tanya Rhodes Rhodes & Associates, Inc 211 Poinciana Lane Largo, FL 33770 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-06-01 |
| Decision Date | 2019-09-20 |
| Summary: | summary |