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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 K841677
Device Name STERILE BLOOD LANCETS
Applicant
Abco Dealers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Abco Dealers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4850
Classification Product Code
FMK  
Date Received04/23/1984
Decision Date 06/11/1984
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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