The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Interlink System-t-connector Extension Set, Model 2n3326.
| Device ID | K060074 |
| 510k Number | K060074 |
| Device Name: | INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD Mcgaw Park, IL 60085 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD Mcgaw Park, IL 60085 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-10 |
| Decision Date | 2006-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412004643 | K060074 | 000 |