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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 K855203
Device Name GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
Applicant
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Applicant Contact JOHN ENGELMANN
Correspondent
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Correspondent Contact JOHN ENGELMANN
Regulation Number878.4850
Classification Product Code
FMK  
Date Received12/26/1985
Decision Date 02/11/1986
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
Predetermined Change
Control Plan Authorized		 No
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