The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Micro Volume Double Line Extension Set.
Device ID | K850061 |
510k Number | K850061 |
Device Name: | MICRO VOLUME DOUBLE LINE EXTENSION SET |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-08 |
Decision Date | 1985-03-27 |