The following data is part of a premarket notification filed by Coloplast Manufacturing Us, Llc with the FDA for Self Cath Catheter.
| Device ID | K100878 |
| 510k Number | K100878 |
| Device Name: | SELF CATH CATHETER |
| Classification | Catheter, Straight |
| Applicant | COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD Minneapolis, MN 55411 |
| Contact | Brian Schmidt |
| Correspondent | Brian Schmidt COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD Minneapolis, MN 55411 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-30 |
| Decision Date | 2010-05-26 |
| Summary: | summary |