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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Wound, Plastic
510(k) Number K910104
Device Name ANTI-FOG DISPOSABLE IV INDUCTION COVER
Applicant
Central Plastic, Inc.
P.O. Box 789
Eldorado,  KS  67042
Applicant Contact CHARLES GREENWELL
Correspondent
Central Plastic, Inc.
P.O. Box 789
Eldorado,  KS  67042
Correspondent Contact CHARLES GREENWELL
Regulation Number878.4014
Classification Product Code
EYF  
Date Received01/03/1991
Decision Date 04/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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