The following data is part of a premarket notification filed by Colorado Catheter Company, Inc. with the FDA for Icath, Sterilesure.
| Device ID | K071496 |
| 510k Number | K071496 |
| Device Name: | ICATH, STERILESURE |
| Classification | Kit, Catheter, Urinary (exludes Hiv Testing) |
| Applicant | COLORADO CATHETER COMPANY, INC. 15975 WINDING TRAIL ROAD Colorado Springs, CO 80908 |
| Contact | Doug Wilson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NWO |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-31 |
| Decision Date | 2007-08-15 |
| Summary: | summary |