The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for I.v. Pump Administration Set.
Device ID | K843949 |
510k Number | K843949 |
Device Name: | I.V. PUMP ADMINISTRATION SET |
Classification | Pump, Infusion |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | John Brda |
Correspondent | John Brda TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-09 |
Decision Date | 1984-11-30 |