The following data is part of a premarket notification filed by Med-sonics Corp. with the FDA for Uretron Pf Series Probe.
| Device ID | K162119 |
| 510k Number | K162119 |
| Device Name: | UreTron PF Series Probe |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | MED-SONICS CORP. 4960 PITTSBURGH AVENUE, SUITE A Erie, PA 16509 |
| Contact | Jennifer Rautine |
| Correspondent | Jennifer Rautine MED-SONICS CORP. 4960 PITTSBURGH AVENUE, SUITE A Erie, PA 16509 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2016-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854732006300 | K162119 | 000 |
| 00854732006294 | K162119 | 000 |