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 | K153410 |
| 510k Number | K153410 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-11-25 |
| Decision Date | 2017-05-15 |
| Summary: | summary |