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 |