The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx710 Series Vascular Access Infusion Set.
Device ID | K874133 |
510k Number | K874133 |
Device Name: | MX710 SERIES VASCULAR ACCESS INFUSION SET |
Classification | Set, Administration, Intravascular |
Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
Contact | P. D Messinger |
Correspondent | P. D Messinger MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-13 |
Decision Date | 1988-01-14 |