Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Establishment Registration & Device Listing
  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Proprietary Name: Folysil
Classification Name: CATHETER, RETENTION TYPE, BALLOON
Product Code: EZL
Device Class: 2
Regulation Number: 876.5130
Medical Specialty: Gastroenterology
Registered Establishment Name: COLOPLAST MANUFACTURING FRANCE, SAS
Registered Establishment Number: 9610711
Premarket Submission Number: K013174
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Manufacturer
-
-