The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Chemo-aide Dispensing Pin.
| Device ID | K003730 |
| 510k Number | K003730 |
| Device Name: | CHEMO-AIDE DISPENSING PIN |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Judy Kannenberg |
| Correspondent | Judy Kannenberg BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2000-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412035135 | K003730 | 000 |