The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Speedicath Compact Set (12 Fr).
| Device ID | K121457 |
| 510k Number | K121457 |
| Device Name: | SPEEDICATH COMPACT SET (12 FR) |
| Classification | Catheter, Urethral |
| Applicant | COLOPLAST CORP. 1601 WEST RIVER RD NORTH Minneapolis, MN 55411 |
| Contact | Brian Schmidt |
| Correspondent | Brian Schmidt COLOPLAST CORP. 1601 WEST RIVER RD 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 | 2012-05-16 |
| Decision Date | 2012-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932534482 | K121457 | 000 |
| 05708932543965 | K121457 | 000 |
| 05708932543941 | K121457 | 000 |