ORIBRUSH - WITH PROTECTIVE TIP - B001— 510(k) K991595
Substantially EquivalentOrifice Medical AB
FDA 510(k) clearance K991595 for ORIBRUSH - WITH PROTECTIVE TIP - B001, Substantially Equivalent on 1999-06-29. Applicant: Orifice Medical AB. Device class: 2.
Clearance details
- Applicant
- Orifice Medical AB
- Product code
- Code HHT
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ystad, SE
Recent devices under product code HHT
view allMore clearances from Orifice Medical AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.