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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K001162
Device Name GOLDFINGER DEVICE
Applicant
MALI-TECH LTD.
POB 454
GINOT SHOMRON,  IL 44853
Applicant Contact AHAVA STEIN
Correspondent
MALI-TECH LTD.
POB 454
GINOT SHOMRON,  IL 44853
Correspondent Contact AHAVA STEIN
Regulation Number878.4850
Classification Product Code
FMK  
Date Received04/10/2000
Decision Date 08/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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