The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 6200 Volumetric Infusion/pumping Blood.
Device ID | K870801 |
510k Number | K870801 |
Device Name: | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-27 |
Decision Date | 1987-09-04 |