The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Liberty System, Pc Polygraf/polygram Uro.
| Device ID | K924383 |
| 510k Number | K924383 |
| Device Name: | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
| Contact | Anna Pettersson |
| Correspondent | Anna Pettersson SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-25 |
| Decision Date | 1993-06-18 |