The following data is part of a premarket notification filed by Coloplast with the FDA for Self-cath And Self-cath Plus.
|Device Name:||Self-Cath And Self-Cath Plus|
|Applicant||Coloplast 1601 West River Road North Minneapolis, MN 55411|
Coloplast 1601 West River Road North Minneapolis, MN 55411
|CFR Regulation Number||876.5130 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|