The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Disposable Plastic Transfus./infus. Assb.
| Device ID | K822354 |
| 510k Number | K822354 |
| Device Name: | DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB |
| Classification | Set, Administration, Intravascular |
| Applicant | VALLEYLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-06 |
| Decision Date | 1982-09-22 |