The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Duploreach.
| Device ID | K014088 |
| 510k Number | K014088 |
| Device Name: | DUPLOREACH |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-12 |
| Decision Date | 2002-06-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DUPLOREACH 78085309 2739049 Live/Registered |
BAXTER INTERNATIONAL INC. 2001-09-24 |
![]() DUPLOREACH 78085309 2739049 Live/Registered |
Baxter Healthcare S.A. 2001-09-24 |