The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model 5790 Gas Chromatograph.
Device ID | K820071 |
510k Number | K820071 |
Device Name: | MODEL 5790 GAS CHROMATOGRAPH |
Classification | Chromatography(gas), Clinical Use |
Applicant | HEWLETT-PACKARD CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KZQ |
CFR Regulation Number | 862.2250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-12 |
Decision Date | 1982-01-28 |