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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 K024170
Device Name L1 SYSTEM
Applicant
Pelikan Technologies, Inc.
1072 E. Meadow Circle
Palo Alto,  CA  94303
Applicant Contact JACK GREEN
Correspondent
Pelikan Technologies, Inc.
1072 E. Meadow Circle
Palo Alto,  CA  94303
Correspondent Contact JACK GREEN
Regulation Number878.4850
Classification Product Code
FMK  
Date Received12/18/2002
Decision Date 04/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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