Dilapan-S— 510(k) K143447
Substantially EquivalentMedicem Technology S.R.O
FDA 510(k) clearance K143447 for Dilapan-S, Substantially Equivalent on 2015-04-17. Applicant: Medicem Technology S.R.O. Device class: 2.
Clearance details
- Applicant
- Medicem Technology S.R.O
- Product code
- Code PKN
- Device class
- Class 2
- Regulation
- 21 CFR 884.4260
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kamenne Zehrovice, CZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.