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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 K902416
Device Name SURELITE AND SURELITE XL BLOOD LANCET
Applicant
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Applicant Contact MARK GAINOR
Correspondent
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Correspondent Contact MARK GAINOR
Regulation Number878.4850
Classification Product Code
FMK  
Date Received05/31/1990
Decision Date 08/01/1990
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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