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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 K820625
Device Name HEMALET AUTOMATIC LANCET DEVICE
Applicant
MEDPROBE LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDPROBE LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4850
Classification Product Code
FMK  
Date Received03/08/1982
Decision Date 04/09/1982
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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