The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Conveen Self-sealing Urisheath Male External Cath.
| Device ID | K854580 |
| 510k Number | K854580 |
| Device Name: | CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | C/o R Hammer/associ |
| Correspondent | C/o R Hammer/associ COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-15 |
| Decision Date | 1985-12-13 |