The following data is part of a premarket notification filed by Jfv, Inc. with the FDA for Iv Set.
Device ID | K901949 |
510k Number | K901949 |
Device Name: | IV SET |
Classification | Set, Administration, Intravascular |
Applicant | JFV, INC. P.O. BOX 348 33 SOUTH MAIN STREET Spencer, IN 47460 |
Contact | Vance, Sr. |
Correspondent | Vance, Sr. JFV, INC. P.O. BOX 348 33 SOUTH MAIN STREET Spencer, IN 47460 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-30 |
Decision Date | 1990-09-12 |