IODOFLEX
Dressing, Wound, Drug
Smith & Nephew Medical Ltd.
The following data is part of a premarket notification filed by Smith & Nephew Medical Ltd. with the FDA for Iodoflex.
Pre-market Notification Details
| Device ID | K190756 |
| 510k Number | K190756 |
| Device Name: | IODOFLEX |
| Classification | Dressing, Wound, Drug |
| Applicant | Smith & Nephew Medical Ltd. 10 I Hessle Road Hull East Riding Of Yorkshire, GB Hu32bn |
| Contact | Meenakshi Gupta |
| Correspondent | Ana Castillo Smith & Nephew Medical Ltd. 10 I Hessle Road Hull East Riding Of Yorkshire, GB Hu32bn |
| 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 | 2019-03-25 |
| Decision Date | 2019-12-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00040565122533 | K190756 | 000 |
| 00040565122519 | K190756 | 000 |
Trademark Results [IODOFLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IODOFLEX 74455774 2034068 Live/Registered |
TJ SMITH & NEPHEW LIMITED 1993-11-09 |
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