The following data is part of a premarket notification filed by Coloplast with the FDA for Speedicath Soft.
| Device ID | K200142 |
| 510k Number | K200142 |
| Device Name: | SpeediCath Soft |
| Classification | Catheter, Urethral |
| Applicant | Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Delaney Mcdougal |
| Correspondent | Delaney Mcdougal Coloplast 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 | 2020-01-22 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932715713 | K200142 | 000 |
| 05708932715676 | K200142 | 000 |
| 05708932715652 | K200142 | 000 |
| 05708932715621 | K200142 | 000 |