The following data is part of a premarket notification filed by Coloplast Manufacturing Us, Llc with the FDA for Self-cath Cs Closed Urinary Catheterization System.
| Device ID | K070939 |
| 510k Number | K070939 |
| Device Name: | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD Minneapolis, MN 55411 |
| Contact | Rebeka Stoltman |
| Correspondent | Rebeka Stoltman COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD Minneapolis, MN 55411 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-04 |
| Decision Date | 2007-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932283083 | K070939 | 000 |
| 05708932282970 | K070939 | 000 |
| 05708932282963 | K070939 | 000 |
| 05708932282956 | K070939 | 000 |
| 05708932282949 | K070939 | 000 |
| 05708932282932 | K070939 | 000 |
| 05708932282925 | K070939 | 000 |
| 05708932282918 | K070939 | 000 |
| 05708932282901 | K070939 | 000 |
| 05708932282987 | K070939 | 000 |
| 05708932282994 | K070939 | 000 |
| 05708932283090 | K070939 | 000 |
| 05708932283076 | K070939 | 000 |
| 05708932283069 | K070939 | 000 |
| 05708932283052 | K070939 | 000 |
| 05708932283045 | K070939 | 000 |
| 05708932283038 | K070939 | 000 |
| 05708932283021 | K070939 | 000 |
| 05708932283014 | K070939 | 000 |
| 05708932282895 | K070939 | 000 |