The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tegaderm Silver (ag) Mesh.
| Device ID | K053256 |
| 510k Number | K053256 |
| Device Name: | 3M TEGADERM SILVER (AG) MESH |
| Classification | Dressing, Wound, Drug |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Amy E Short |
| Correspondent | Amy E Short 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-11-22 |
| Decision Date | 2005-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387565331 | K053256 | 000 |
| 50707387565324 | K053256 | 000 |
| 50707387565317 | K053256 | 000 |
| 50707387565300 | K053256 | 000 |