The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Resubmitted Micron Transfusion Filter.
Device ID | K873873 |
510k Number | K873873 |
Device Name: | RESUBMITTED MICRON TRANSFUSION FILTER |
Classification | Microfilter, Blood Transfusion |
Applicant | TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Contact | Dennis Ocwieja |
Correspondent | Dennis Ocwieja TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Product Code | CAK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-31 |
Decision Date | 1987-10-22 |