The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Duplogrip.
Device ID | K003193 |
510k Number | K003193 |
Device Name: | DUPLOGRIP |
Classification | Syringe, Piston |
Applicant | BAXTER HEALTHCARE CORP. 550 NORTH BRAND BLVD. Glendale, CA 91023 |
Contact | Arlene Vidor |
Correspondent | Arlene Vidor BAXTER HEALTHCARE CORP. 550 NORTH BRAND BLVD. Glendale, CA 91023 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-12 |
Decision Date | 2000-11-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DUPLOGRIP 78029225 2712129 Dead/Cancelled |
Baxter International Inc. 2000-10-05 |