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 |