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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Margin Finishing, Operative
510(k) Number K872622
Device Name ORTHODONTIC ARCH
Applicant
Wonder Wire
P.O. Box 6499
Wyomissing,  PA  19610
Applicant Contact WOOL, DDS
Correspondent
Wonder Wire
P.O. Box 6499
Wyomissing,  PA  19610
Correspondent Contact WOOL, DDS
Regulation Number872.4565
Classification Product Code
EJZ  
Date Received07/06/1987
Decision Date 10/09/1987
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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