The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab I.v. Administration Sets.
| Device ID | K883318 |
| 510k Number | K883318 |
| Device Name: | VALLEYLAB I.V. ADMINISTRATION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-05 |
| Decision Date | 1988-10-21 |