The following data is part of a premarket notification filed by H & S Technical Services with the FDA for H&s-conductivity Standard Solution.
| Device ID | K041636 |
| 510k Number | K041636 |
| Device Name: | H&S-CONDUCTIVITY STANDARD SOLUTION |
| Classification | Solution-test Standard-conductivity, Dialysis |
| Applicant | H & S TECHNICAL SERVICES 1833 W. MAIN STREET STE. 119 Mesa, AZ 85201 |
| Contact | John Hyte |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FKH |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-17 |
| Decision Date | 2004-07-02 |
| Summary: | summary |