The following data is part of a premarket notification filed by Richard James, Inc. with the FDA for Fts-100 Fluid Transfer System.
Device ID | K902835 |
510k Number | K902835 |
Device Name: | FTS-100 FLUID TRANSFER SYSTEM |
Classification | Pump, Infusion |
Applicant | RICHARD JAMES, INC. P.O. BOX 309 Lynnfield, MA 01940 |
Contact | Wayne A Richard |
Correspondent | Wayne A Richard RICHARD JAMES, INC. P.O. BOX 309 Lynnfield, MA 01940 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-28 |
Decision Date | 1990-08-10 |