CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER— 510(k) K946243
Substantially EquivalentColoplast A/S
FDA 510(k) clearance K946243 for CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER, Substantially Equivalent on 1995-02-13. Applicant: Coloplast A/S.
Clearance details
- Applicant
- Coloplast A/S
- Product code
- Code EXJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.