The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Cahp High Performance Cellulose Diacetate (capillary, Hollow Fiber).
Device ID | K970653 |
510k Number | K970653 |
Device Name: | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) |
Classification | Hemodialyzer, Re-use, High Flux |
Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
Contact | Robert L Wilkinson |
Correspondent | Robert L Wilkinson BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
Product Code | MSF |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-21 |
Decision Date | 1998-03-11 |
Summary: | summary |