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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 K041665
Device Name L1-PRO SYSTEM
Applicant
PELIKAN TECHNOLOGIES, INC
1072 EAST MEADOW CIRCLE
PALO ALTO,  CA  94303
Applicant Contact JACK S GREEN
Correspondent
PELIKAN TECHNOLOGIES, INC
1072 EAST MEADOW CIRCLE
PALO ALTO,  CA  94303
Correspondent Contact JACK S GREEN
Regulation Number878.4850
Classification Product Code
FMK  
Date Received06/18/2004
Decision Date 07/23/2004
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
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