The following data is part of a premarket notification filed by Cardinal Health 303, Inc. with the FDA for Signature Edition Gold Infusion System, Model 7x3x.
| Device ID | K063288 |
| 510k Number | K063288 |
| Device Name: | SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X |
| Classification | Pump, Infusion |
| Applicant | CARDINAL HEALTH 303, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Contact | Stacy L Lewis |
| Correspondent | Stacy L Lewis CARDINAL HEALTH 303, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2006-11-28 |
| Summary: | summary |