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 |