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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Thermometer, Clinical Mercury
510(k) Number K923225
Device Name LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME
Applicant
Lorrex Health Products
301 Penhorn Ave.
Secaucus,  NJ  07094
Applicant Contact ERIC M MORALES
Correspondent
Lorrex Health Products
301 Penhorn Ave.
Secaucus,  NJ  07094
Correspondent Contact ERIC M MORALES
Regulation Number880.2920
Classification Product Code
FLK  
Date Received07/01/1992
Decision Date 06/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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