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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 K883420
Device Name LANCET, BLOOD
Applicant
PRIMROSE MEDICAL, INC.
20 CABOT RD.
WOBURN,  MA  01801
Applicant Contact FLETCHER LONGLEY
Correspondent
PRIMROSE MEDICAL, INC.
20 CABOT RD.
WOBURN,  MA  01801
Correspondent Contact FLETCHER LONGLEY
Regulation Number878.4850
Classification Product Code
FMK  
Date Received08/15/1988
Decision Date 08/26/1988
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
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