The following data is part of a premarket notification filed by Dial Medical Supply with the FDA for Dialysis Mixing & Holding Tank.
Device ID | K961416 |
510k Number | K961416 |
Device Name: | DIALYSIS MIXING & HOLDING TANK |
Classification | Tank, Holding, Dialysis |
Applicant | DIAL MEDICAL SUPPLY 1990 INDUSTRIAL DR. Deland, FL 32724 |
Contact | Matthew M Hull |
Correspondent | Matthew M Hull DIAL MEDICAL SUPPLY 1990 INDUSTRIAL DR. Deland, FL 32724 |
Product Code | FIN |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-12 |
Decision Date | 1996-08-21 |