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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 K863621
Device Name PALS
Applicant
West Lake Marketing
75 Executive Dr.
Westerville,  OH  43081
Applicant Contact DOUGLAS R HUFNAGLE
Correspondent
West Lake Marketing
75 Executive Dr.
Westerville,  OH  43081
Correspondent Contact DOUGLAS R HUFNAGLE
Regulation Number878.4850
Classification Product Code
FMK  
Date Received09/16/1986
Decision Date 10/06/1986
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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