The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Iv Administration Set Fpa.
Device ID | K944208 |
510k Number | K944208 |
Device Name: | IV ADMINISTRATION SET FPA |
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 | 1994-08-29 |
Decision Date | 1994-12-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50351688505697 | K944208 | 000 |
30351688516477 | K944208 | 000 |
50351688506922 | K944208 | 000 |
50351688506878 | K944208 | 000 |