The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Colleague Pump Syringe Adapter Set.
Device ID | K982672 |
510k Number | K982672 |
Device Name: | COLLEAGUE PUMP SYRINGE ADAPTER SET |
Classification | Set, Administration, Intravascular |
Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
Contact | Linda Coleman |
Correspondent | Linda Coleman BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-31 |
Decision Date | 1998-09-04 |
Summary: | summary |