The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Compartmental Pressure Monitoring System.
| Device ID | K031555 |
| 510k Number | K031555 |
| Device Name: | SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | LXC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6795304130 | K031555 | 000 |
| H6795304120 | K031555 | 000 |
| H6795304110 | K031555 | 000 |