The following data is part of a premarket notification filed by Breem Laboratories with the FDA for Hemodialysis Concentrates And Related Products.
| Device ID | K860336 |
| 510k Number | K860336 |
| Device Name: | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | BREEM LABORATORIES 8931 SOUTH VERMONT AVE. Los Angeles, CA 90044 |
| Contact | James Stewart |
| Correspondent | James Stewart BREEM LABORATORIES 8931 SOUTH VERMONT AVE. Los Angeles, CA 90044 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-29 |
| Decision Date | 1986-03-04 |