INSERTEASE— 510(k) K092829
Substantially EquivalentChristcot Medical Company
FDA 510(k) clearance K092829 for INSERTEASE, Substantially Equivalent on 2009-12-02. Applicant: Christcot Medical Company. Device class: 1.
Clearance details
- Applicant
- Christcot Medical Company
- Product code
- Code OOW
- Device class
- Class 1
- Regulation
- 21 CFR 876.4730
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sudbury, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.