510(k) K110288
K110288 is an FDA 510(k) premarket notification submitted by Femasys, Inc. for the device "FEMVUE SALINE-AIR DEVICE". The FDA issued a decision of Substantially Equivalent on April 28, 2011. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Femasys, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2011
- Date Received
- February 1, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Manipulator/Injector, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type