The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Contrast Control Device.
| Device ID | K982123 |
| 510k Number | K982123 |
| Device Name: | CONTRAST CONTROL DEVICE |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Contact | Cindy Chenetski |
| Correspondent | Cindy 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 | 1998-06-16 |
| Decision Date | 1998-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333208887 | K982123 | 000 |
| 40889942856009 | K982123 | 000 |