The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for 0.9% Sodium Chloride Flush Syringe.
Device ID | K984590 |
510k Number | K984590 |
Device Name: | 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
Contact | Marcia Marconi |
Correspondent | Marcia Marconi BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-28 |
Decision Date | 1999-10-07 |
Summary: | summary |