The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Duploject Easy-prep System 1ml, 2ml, 5ml.
| Device ID | K020666 |
| 510k Number | K020666 |
| Device Name: | DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML |
| Classification | Syringe, Piston |
| Applicant | BAXTER HEALTHCARE CORP. 550 N. BRAND BLVD. Glendale, CA 91203 -1900 |
| Contact | Arlene Vidor |
| Correspondent | Arlene Vidor BAXTER HEALTHCARE CORP. 550 N. BRAND BLVD. Glendale, CA 91203 -1900 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-01 |
| Decision Date | 2002-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412095849 | K020666 | 000 |
| 50085412095832 | K020666 | 000 |
| 50085412095634 | K020666 | 000 |