510(k) K143447
K143447 is an FDA 510(k) premarket notification submitted by Medicem Technology S.R.O for the device "Dilapan-S". The FDA issued a decision of Substantially Equivalent on April 17, 2015. The device falls under product code PKN (Dilator, Cervical, Synthetic, Osmotic), a Class II device regulated under 21 CFR 884.4260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2015
- Date Received
- December 2, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Cervical, Synthetic, Osmotic
- Device Class
- Class II
- Regulation Number
- 884.4260
- Review Panel
- OB
- Submission Type
Cervical softening and dilation