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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 K843722
Device Name ORTHODONTIC WIRE
Applicant
Arthur L. Wool
1402 Penn Ave.
Wyomissing,  PA  19610
Correspondent
Arthur L. Wool
1402 Penn Ave.
Wyomissing,  PA  19610
Regulation Number872.5410
Classification Product Code
DZC  
Date Received09/24/1984
Decision Date 11/09/1984
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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