The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Low Plasticizer Administration Sets.
| Device ID | K791496 |
| 510k Number | K791496 |
| Device Name: | LOW PLASTICIZER ADMINISTRATION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | TRAVENOL LABORATORIES, S.A. 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 | 1979-08-03 |
| Decision Date | 1980-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412075285 | K791496 | 000 |
| 50085412075278 | K791496 | 000 |