The following data is part of a premarket notification filed by Bob J. Johnson & Associates with the FDA for Water Purification Components For Hemodialysis.
Device ID | K060942 |
510k Number | K060942 |
Device Name: | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS |
Classification | Subsystem, Water Purification |
Applicant | BOB J. JOHNSON & ASSOCIATES 16420 W. HARDY RD., STE. 100 Houston, TX 77060 |
Contact | Jon Hulsey |
Correspondent | Jon Hulsey BOB J. JOHNSON & ASSOCIATES 16420 W. HARDY RD., STE. 100 Houston, TX 77060 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-06 |
Decision Date | 2006-07-07 |
Summary: | summary |