The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tegaderm Chg Dressing.
| Device ID | K063458 |
| 510k Number | K063458 |
| Device Name: | 3M TEGADERM CHG DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | 3M COMPANY 3M CENTER BUILDING 275-05W-06 St. Paul, MN 55144 |
| Contact | Maria Ruiz |
| Correspondent | Maria Ruiz 3M COMPANY 3M CENTER BUILDING 275-05W-06 St. Paul, MN 55144 |
| 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 | 2006-11-15 |
| Decision Date | 2007-04-05 |
| Summary: | summary |