Dilapan-S
FDA 510(k) clearance K143447 · decided 2015-04-17
Clearance details
- K-number
- K143447
- Device name
- Dilapan-S
- Applicant
- Medicem Technology S.R.O
- Decision
- Substantially Equivalent
- Date received
- 2014-12-02
- Decision date
- 2015-04-17
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- PKN
- Device class
- 2
- Regulation number
- 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Kamenne Zehrovice, CZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DILAPAN-S (P840045/S006) | Medicem Technology S.R.O | 2002-10-25 |
| DILAPAN(TM) (P840045/S002) | Medicem Technology S.R.O | 1988-09-28 |
| DILAPAN(TM) (P840045/S003) | Medicem Technology S.R.O | 1987-12-14 |
| DILAPAN-S CERVICAL DILATOR (P840045) | Medicem Technology S.R.O | 1986-04-28 |