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 |