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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 K880869
Device Name MEDI-LET
Applicant
Medicore, Inc.
2201 W. 76th St.
Hialeah,  FL  33016
Applicant Contact DANIEL J CHIODO
Correspondent
Medicore, Inc.
2201 W. 76th St.
Hialeah,  FL  33016
Correspondent Contact DANIEL J CHIODO
Regulation Number878.4850
Classification Product Code
FMK  
Date Received03/01/1988
Decision Date 03/21/1988
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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