510(k) K093508
K093508 is an FDA 510(k) premarket notification submitted by Womancare Global for the device "RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)". The FDA issued a decision of Substantially Equivalent on March 4, 2010. The device falls under product code HGH (Cannula, Suction, Uterine), a Class II device regulated under 21 CFR 884.5070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2010
- Date Received
- November 12, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Suction, Uterine
- Device Class
- Class II
- Regulation Number
- 884.5070
- Review Panel
- OB
- Submission Type