The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Cleo 90 Infusion Set.
| Device ID | K042172 |
| 510k Number | K042172 |
| Device Name: | CLEO 90 INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Contact | David H Short |
| Correspondent | David H Short SMITHS MEDICAL MD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-11 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30610586028414 | K042172 | 000 |
| 30610586028407 | K042172 | 000 |
| 30610586028391 | K042172 | 000 |
| 30610586028353 | K042172 | 000 |
| 30610586028346 | K042172 | 000 |
| 30610586028339 | K042172 | 000 |