The following data is part of a premarket notification filed by Y with the FDA for Ez Administration Set.
Device ID | K931550 |
510k Number | K931550 |
Device Name: | EZ ADMINISTRATION SET |
Classification | Set, Administration, Intravascular |
Applicant | Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
Contact | Jennifer S Hankard |
Correspondent | Jennifer S Hankard Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-29 |
Decision Date | 1994-01-10 |