510(k) K071496
- Device
- ICATH, STERILESURE
- Applicant
- COLORADO CATHETER COMPANY, INC.
- 510(k) number
- K071496
- Product code
- NWO
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2007-08-15
- Date received
- 2007-05-31
- Regulation
- 876.5130
- Classification name
- Kit, Catheter, Urinary (exludes Hiv Testing)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- DOUG WILSON
- Address
- 15975 Winding Trl. Rd. Colorado Springs CO US 80908 80908
Source Documents#
Legacy Summary#
summary
FDA Review#
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