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 |