The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Heparin Lock Flush Syring 10 Usp Units/ml, Heparin Lock Flush Syringe, 100 Usp Units/ml.
Device ID | K003245 |
510k Number | K003245 |
Device Name: | HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
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 | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-17 |
Decision Date | 2000-12-04 |