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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 K865016
Device Name BLOOD LANCET
Applicant
Falcon Medical Industries, Inc.
1640 N. Newport Ave.
Delano,  FL  32724
Applicant Contact STEVE TRAPPER
Correspondent
Falcon Medical Industries, Inc.
1640 N. Newport Ave.
Delano,  FL  32724
Correspondent Contact STEVE TRAPPER
Regulation Number878.4850
Classification Product Code
FMK  
Date Received12/23/1986
Decision Date 01/12/1987
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
Predetermined Change
Control Plan Authorized		 No
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