The following data is part of a premarket notification filed by Y with the FDA for Ivac Needle Free Valve Administration Sets.
Device ID | K960280 |
510k Number | K960280 |
Device Name: | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS |
Classification | Set, Administration, Intravascular |
Applicant | Y 10300 CAMPUS POINT DR. San Diego, CA 92121 -1579 |
Contact | Jennifer S Hankard |
Correspondent | Jennifer S Hankard Y 10300 CAMPUS POINT DR. San Diego, CA 92121 -1579 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-19 |
Decision Date | 1996-04-04 |
Summary: | summary |