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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 K850100
Device Name BLOOD LANCET
Applicant
GAINOR MEDICAL
12520 YELLOWHEAD TRAIL
Applicant Contact MARK GAINOR
Correspondent
GAINOR MEDICAL
12520 YELLOWHEAD TRAIL
Correspondent Contact MARK GAINOR
Regulation Number878.4850
Classification Product Code
FMK  
Date Received01/11/1985
Decision Date 01/29/1987
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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