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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Orthodontic
510(k) Number K843171
Device Name FILAFEX TM, ESTHETIC ORTHODONTIC WIRE
Applicant
Berkley and Co.
Trilene Dr.
Spirit Lake,  IA  51360
Applicant Contact BOB SNEITZER
Correspondent
Berkley and Co.
Trilene Dr.
Spirit Lake,  IA  51360
Correspondent Contact BOB SNEITZER
Regulation Number872.5410
Classification Product Code
DZC  
Date Received08/13/1984
Decision Date 12/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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