The following data is part of a premarket notification filed by 3m Company, 3m Health Care with the FDA for 3m Tegaderm Antimicrobial Transparent Dressing, 3m Tegaderm Antimicrobial I.v. Advanced Securement Dressing.
Device ID | K170754 |
510k Number | K170754 |
Device Name: | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing |
Classification | Dressing, Wound, Drug |
Applicant | 3M Company, 3M Health Care 3M Center, 2510 Conway Ave., Bldg 275-5W-06 St. Paul, MN 55144 |
Contact | Maria Ruiz |
Correspondent | Maria Ruiz 3M Company, 3M Health Care 3M Center, 2510 Conway Ave., Bldg 275-5W-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 | 2017-03-13 |
Decision Date | 2017-11-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50707387785906 | K170754 | 000 |
50707387785845 | K170754 | 000 |
50707387785920 | K170754 | 000 |
50707387785869 | K170754 | 000 |
50707387793321 | K170754 | 000 |
50707387793307 | K170754 | 000 |