The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Conveen(r) Self-sealing Urisheath Male Exter Cath.
| Device ID | K924407 |
| 510k Number | K924407 |
| Device Name: | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-25 |
| Decision Date | 1992-09-23 |