The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Dual Luer Lock Cap, Model 2c6250.
| Device ID | K101385 |
| 510k Number | K101385 |
| Device Name: | DUAL LUER LOCK CAP, MODEL 2C6250 |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-18 |
| Decision Date | 2010-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412036316 | K101385 | 000 |