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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 K810681
Device Name MEDI-LANCE
Applicant
MEDICORE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDICORE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4850
Classification Product Code
FMK  
Date Received03/13/1981
Decision Date 03/26/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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