The following data is part of a premarket notification filed by Icu Medical Inc with the FDA for Diana Medication Transfer Set.
| Device ID | K170110 |
| 510k Number | K170110 |
| Device Name: | Diana Medication Transfer Set |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | ICU MEDICAL INC 951 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Jason Ma |
| Correspondent | Jason Ma ICU MEDICAL INC 600 N. Field Drive Lake Forest, IL 60045 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-12 |
| Decision Date | 2018-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709099163 | K170110 | 000 |
| 10887709090511 | K170110 | 000 |