The following data is part of a premarket notification filed by Valley West, Inc. with the FDA for 1000 Pressure Infusion Sigmacon 1000.
| Device ID | K990447 |
| 510k Number | K990447 |
| Device Name: | 1000 PRESSURE INFUSION SIGMACON 1000 |
| Classification | Pump, Infusion |
| Applicant | VALLEY WEST, INC. HWY. 6 NORTH, P.O. BOX 678 Meridian, TX 76665 |
| Contact | C. Kenneth French |
| Correspondent | C. Kenneth French VALLEY WEST, INC. HWY. 6 NORTH, P.O. BOX 678 Meridian, TX 76665 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-12 |
| Decision Date | 1999-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405048026 | K990447 | 000 |
| 30653405040952 | K990447 | 000 |
| 30653405040938 | K990447 | 000 |