The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Conveen(r) Self-sealing Urisheath Male External Catheter.
| Device ID | K946243 |
| 510k Number | K946243 |
| Device Name: | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | COLOPLAST A/S 1955 WEST OAK CIRCLE Marietta, GA 30062 -2249 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-22 |
| Decision Date | 1995-02-13 |