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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 K931827
Device Name CLEANLET, CLEANLET XL & KIDS
Applicant
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Applicant Contact MARK J GAINOR
Correspondent
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Correspondent Contact MARK J GAINOR
Regulation Number878.4850
Classification Product Code
FMK  
Date Received04/08/1993
Decision Date 09/13/1993
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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