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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 K894427
Device Name DISPOSABLE IV INDUCTION COVER
Applicant
CENTRAL PLASTIC, INC.
P.O. BOX 789
ELDORADO,  KS  67042
Applicant Contact PHILIP HISLE
Correspondent
CENTRAL PLASTIC, INC.
P.O. BOX 789
ELDORADO,  KS  67042
Correspondent Contact PHILIP HISLE
Regulation Number878.4850
Classification Product Code
FMK  
Date Received07/17/1989
Decision Date 09/11/1989
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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