510(k) K140305
K140305 is an FDA 510(k) premarket notification submitted by Kessel Medintim GmbH for the device "CAYA CONTOURED DIAPHRAGM". The FDA issued a decision of Substantially Equivalent on Aug 26, 2014. The device falls under product code HDW (Diaphragm, Contraceptive (And Accessories)), a Class II device regulated under 21 CFR 884.5350.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 26, 2014
- Date Received
- Feb 7, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Diaphragm, Contraceptive (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.5350
- Review Panel
- OB
- Submission Type
- 510(k)