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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 K933377
Device Name STAINLESS STEEL ARCHES REPACKER RELABETER
Applicant
HIGHLAND METALS
P.O. BOX 23216
SAN JOSE,  CA  95153
Applicant Contact KENNETH HIGHLAND
Correspondent
HIGHLAND METALS
P.O. BOX 23216
SAN JOSE,  CA  95153
Correspondent Contact KENNETH HIGHLAND
Regulation Number872.5410
Classification Product Code
DZC  
Date Received07/09/1993
Decision Date 11/16/1993
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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