The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Syringe Infusion Pump.
Device ID | K860353 |
510k Number | K860353 |
Device Name: | SYRINGE INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | TRAVENOL LABORATORIES, S.A. LONDONDERRY TURNPIKE Hooksett, NH 03104 |
Contact | Roger A Leroux |
Correspondent | Roger A Leroux TRAVENOL LABORATORIES, S.A. LONDONDERRY TURNPIKE Hooksett, NH 03104 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-30 |
Decision Date | 1986-09-05 |