The following data is part of a premarket notification filed by 3m Health Care with the FDA for Cavilon Advanced High Endurance Skin Protectant.
| Device ID | K153571 |
| 510k Number | K153571 |
| Device Name: | Cavilon Advanced High Endurance Skin Protectant |
| Classification | Bandage, Liquid |
| Applicant | 3M HEALTH CARE 3M CENTER, 2510 CONWAY AVE., BLDG 275-5W-06 St.paul, MN 55144 |
| Contact | Maria Ruiz |
| Correspondent | Maria Ruiz 3M HEALTH CARE 3M CENTER, 2510 CONWAY AVE., BLDG 275-5W-06 St. Paul, MN 55144 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-15 |
| Decision Date | 2016-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387773361 | K153571 | 000 |
| 50707387787306 | K153571 | 000 |
| 00707387788056 | K153571 | 000 |
| 50707387810691 | K153571 | 000 |
| 50707387810684 | K153571 | 000 |