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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, disposable
510(k) Number K821166
Device Name KOLOR KODE TM
Applicant
DEVON INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DEVON INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
KDC  
Date Received04/26/1982
Decision Date 05/13/1982
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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