The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Compressar Universal (tm) System.
| Device ID | K925809 |
| 510k Number | K925809 |
| Device Name: | COMPRESSAR UNIVERSAL (TM) SYSTEM |
| Classification | Clamp, Vascular |
| Applicant | INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Contact | Herbert J Semler |
| Correspondent | Herbert J Semler INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-17 |
| Decision Date | 1993-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815614020545 | K925809 | 000 |
| 10815614020514 | K925809 | 000 |
| 10815614020460 | K925809 | 000 |