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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Suturing, Disposable
510(k) Number K812444
Device Name RADIATION STERILIZATION FOR NEEDLE CNTR
Applicant
DEVON INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DEVON INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GAB  
Date Received08/28/1981
Decision Date 12/14/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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