The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tegaderm Matrix Dressing.
Device ID | K110457 |
510k Number | K110457 |
Device Name: | 3M TEGADERM MATRIX DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -3275 |
Contact | Maria Ruiz |
Correspondent | Maria Ruiz 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -3275 |
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 | 2011-02-17 |
Decision Date | 2011-12-07 |
Summary: | summary |