The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Nu-site.
Device ID | K943897 |
510k Number | K943897 |
Device Name: | NU-SITE |
Classification | Set, Administration, Intravascular |
Applicant | MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
Contact | Cathy Chenetski |
Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-10 |
Decision Date | 1995-02-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50351688500685 | K943897 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NU-SITE 74407742 1928534 Live/Registered |
SMITHS MEDICAL ASD, INC. 1993-06-28 |