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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 K861151
Device Name SUEL BLOOD LANCET
Applicant
EXEL INTL.
P.O. BOX 3194
CULVER CITY,  CA  90231 -3194
Applicant Contact ESHAGH HAMID
Correspondent
EXEL INTL.
P.O. BOX 3194
CULVER CITY,  CA  90231 -3194
Correspondent Contact ESHAGH HAMID
Regulation Number878.4850
Classification Product Code
FMK  
Date Received03/26/1986
Decision Date 04/15/1986
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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