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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 K931631
Device Name COATED ORTHODONTIC DEVICES
Applicant
Wonder Wire
P.O. Box 6499
Wyomissing,  PA  19610
Applicant Contact ARTHUR L WOOL
Correspondent
Wonder Wire
P.O. Box 6499
Wyomissing,  PA  19610
Correspondent Contact ARTHUR L WOOL
Regulation Number872.5410
Classification Product Code
DZC  
Date Received04/02/1993
Decision Date 07/28/1993
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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