The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for 20 Micron High Capacity Trans/filter.
| Device ID | K830057 |
| 510k Number | K830057 |
| Device Name: | 20 MICRON HIGH CAPACITY TRANS/FILTER |
| Classification | Microfilter, Blood Transfusion |
| Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-07 |
| Decision Date | 1983-01-26 |