The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Fixomull.
Device ID | K792725 |
510k Number | K792725 |
Device Name: | FIXOMULL |
Classification | Strip, Adhesive, Closure, Skin |
Applicant | BEIERSDORF, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-31 |
Decision Date | 1980-03-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FIXOMULL 85943798 4469833 Live/Registered |
BSN MEDICAL GMBH 2013-05-28 |