The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Additive Cap.
| Device ID | K111217 |
| 510k Number | K111217 |
| Device Name: | ADDITIVE CAP |
| Classification | Container, I.v. |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAULKEGAN RD. Mcgaw Park, IL 60085 -6730 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORP. 1620 WAULKEGAN RD. Mcgaw Park, IL 60085 -6730 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412003257 | K111217 | 000 |