The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Speedicath Compact.
| Device ID | K072808 |
| 510k Number | K072808 |
| Device Name: | SPEEDICATH COMPACT |
| Classification | Catheter, Urethral |
| Applicant | COLOPLAST CORP. 1601 WEST RIVER N Minneapolis, MN 55411 |
| Contact | Rebeka Stoltman |
| Correspondent | Rebeka Stoltman COLOPLAST CORP. 1601 WEST RIVER N 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 | 2007-10-01 |
| Decision Date | 2007-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932640572 | K072808 | 000 |
| 05708932558952 | K072808 | 000 |
| 05708932558921 | K072808 | 000 |
| 05708932558907 | K072808 | 000 |
| 05708932640527 | K072808 | 000 |
| 05708932640534 | K072808 | 000 |
| 05708932024693 | K072808 | 000 |