The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Continu-flo Solution Admin. Set W/in-line Filter.
Device ID | K865029 |
510k Number | K865029 |
Device Name: | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER |
Classification | Filter, Infusion Line |
Applicant | TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Contact | Julia A Meyer |
Correspondent | Julia A Meyer TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-23 |
Decision Date | 1987-04-17 |