Dilapan-S
Dilator, Cervical, Synthetic, Osmotic
Medicem Technology S.r.o.
The following data is part of a premarket notification filed by Medicem Technology S.r.o. with the FDA for Dilapan-s.
Pre-market Notification Details
| Device ID | K143447 |
| 510k Number | K143447 |
| Device Name: | Dilapan-S |
| Classification | Dilator, Cervical, Synthetic, Osmotic |
| Applicant | Medicem Technology S.r.o. Karlovarska Trida 20 Kamenne Zehrovice, CZ 273 01 |
| Contact | Adam Vlcek |
| Correspondent | Susanne Parks Susanne Parks 206 Ellington Road Graham, NC 27253 |
| Product Code | PKN |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-02 |
| Decision Date | 2015-04-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08595231700291 | K143447 | 000 |
| 08595231700345 | K143447 | 000 |
| 08595231700321 | K143447 | 000 |
Trademark Results [Dilapan-S]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DILAPAN-S 79183084 5080094 Live/Registered |
MEDICEM Technology s.r.o. 2015-12-22 |
 DILAPAN-S 76173875 2729892 Dead/Cancelled |
MEDICEM INTERNATIONAL GMBH 2000-12-01 |
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