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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 K944948
Device Name FREE-LANCE
Applicant
F.F.F. Enterprises, Inc.
27532 Commerce Center Dr.
Temecula,  CA  92590
Applicant Contact DREW A ARNOLD
Correspondent
F.F.F. Enterprises, Inc.
27532 Commerce Center Dr.
Temecula,  CA  92590
Correspondent Contact DREW A ARNOLD
Regulation Number878.4850
Classification Product Code
FMK  
Date Received10/07/1994
Decision Date 11/17/1994
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
Predetermined Change
Control Plan Authorized		 No
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