The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for 6060 Multi-therapy Pump, Model 2m9832; 6060 Epidural Pump, Model 2l9351.
Device ID | K002679 |
510k Number | K002679 |
Device Name: | 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 |
Classification | Pump, Infusion |
Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
Contact | Jennifer M Paine |
Correspondent | Jennifer M Paine BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-28 |
Decision Date | 2000-09-18 |