The following data is part of a premarket notification filed by Lorrex Health Products with the FDA for Lorrex Health Products - Clinical Mercury Thermome.
| Device ID | K923225 |
| 510k Number | K923225 |
| Device Name: | LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME |
| Classification | Thermometer, Clinical Mercury |
| Applicant | LORREX HEALTH PRODUCTS 301 PENHORN AVE. Secaucus, NJ 07094 |
| Contact | Eric M Morales |
| Correspondent | Eric M Morales LORREX HEALTH PRODUCTS 301 PENHORN AVE. Secaucus, NJ 07094 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1993-06-08 |