The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Cadd Administration Set With Flow Stop, Medication Cassette Reservoir With Flow Stop And Extension Set.
| Device ID | K040636 |
| 510k Number | K040636 |
| Device Name: | CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Patricia A Laforte |
| Correspondent | Patricia A Laforte SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. 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 | 2004-03-10 |
| Decision Date | 2004-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517184239 | K040636 | 000 |
| 35019517191824 | K040636 | 000 |
| 30610586029657 | K040636 | 000 |