The following data is part of a premarket notification filed by Cerkamed Wojciech Pawlowski with the FDA for Cleanser Root Canal.
| Device ID | K130180 |
| 510k Number | K130180 |
| Device Name: | CLEANSER ROOT CANAL |
| Classification | Cleanser, Root Canal |
| Applicant | CERKAMED WOJCIECH PAWLOWSKI KWIATKOWSKIEGO 1 STREET Stalowa Wola, Podkarpacie, PL 37-450 |
| Contact | Kinga Wierucka |
| Correspondent | Kinga Wierucka CERKAMED WOJCIECH PAWLOWSKI KWIATKOWSKIEGO 1 STREET Stalowa Wola, Podkarpacie, PL 37-450 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-25 |
| Decision Date | 2013-10-03 |
| Summary: | summary |