510(k) K143447
- Device
- Dilapan-S
- Applicant
- Medicem Technology S.r.o.
- 510(k) number
- K143447
- Product code
- PKN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-17
- Date received
- 2014-12-02
- Regulation
- 884.4260
- Classification name
- Dilator, Cervical, Synthetic, Osmotic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Adam Vlcek
- Address
- Karlovarska Trida 20 Kamenne Zehrovice CZ 273 01 273 01
FDA Registration Numbers#
- 3003994796
Source Documents#
Legacy Summary#
summary
FDA Review#
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