The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Speedicath Compact Male.
| Device ID | K143182 |
| 510k Number | K143182 |
| Device Name: | Speedicath Compact Male |
| Classification | Catheter, Urethral |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Brian Schmidt |
| Correspondent | Brian Schmidt COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-05 |
| Decision Date | 2015-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932624688 | K143182 | 000 |
| 05708932024709 | K143182 | 000 |
| 05708932698337 | K143182 | 000 |