The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox Hemoconcentrator.
Device ID | K973516 |
510k Number | K973516 |
Device Name: | CAPIOX HEMOCONCENTRATOR |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Sandi Hartka |
Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | KDI |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-17 |
Decision Date | 1998-01-30 |
Summary: | summary |