The following data is part of a premarket notification filed by Specialty Fibres And Materials Ltd with the FDA for Titan Ag 200.
| Device ID | K173844 |
| 510k Number | K173844 |
| Device Name: | Titan Ag 200 |
| Classification | Dressing, Wound, Drug |
| Applicant | Specialty Fibres And Materials Ltd 101 Lockhurst Lane Coventry, GB Cv6 5sf |
| Contact | Lindie Marx |
| Correspondent | Lindie Turvey Specialty Fibres And Materials Ltd 101 Lockhurst Lane Coventry, GB Cv6 5sf |
| 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 | 2017-12-19 |
| Decision Date | 2018-08-09 |
| Summary: | summary |