The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tegaderm Chg Chlorhexidine Gluconate I.v. Securement Dressing.
Device ID | K171908 |
510k Number | K171908 |
Device Name: | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing |
Classification | Dressing, Wound, Drug |
Applicant | 3M Company 3M Center, 2510 Conway Ave, Bldg 275-5W-06 St. Paul, MN 55144 |
Contact | Melissa Forth |
Correspondent | Melissa Forth 3M Company 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 | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2017-06-26 |
Decision Date | 2017-07-11 |
Summary: | summary |