The following data is part of a premarket notification filed by Speciality Fibres And Materials Ltd. with the FDA for Suprasorb A + Ag “r”.
| Device ID | K183208 |
| 510k Number | K183208 |
| Device Name: | Suprasorb A + Ag “R” |
| Classification | Dressing, Wound, Drug |
| Applicant | Speciality Fibres And Materials Ltd. 101 Lockhurst Lane Coventry, GB Cv6 5sf |
| Contact | Lindie Turvey |
| Correspondent | Lindie Turvey Speciality 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 | 2018-11-19 |
| Decision Date | 2019-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060786987556 | K183208 | 000 |
| 05060786987549 | K183208 | 000 |