The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Auto Syringe Micro Vol Ext Set W/air Vent Filter.
Device ID | K860746 |
510k Number | K860746 |
Device Name: | AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER |
Classification | Filter, Infusion Line |
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 | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-27 |
Decision Date | 1986-04-07 |