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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 K935638
Device Name NITINOL, NITI
Applicant
Highland Metals
1801 Almaden Rd.
Unit C
San Jose,  CA  95125
Applicant Contact KENNETH HIGHLAND
Correspondent
Highland Metals
1801 Almaden Rd.
Unit C
San Jose,  CA  95125
Correspondent Contact KENNETH HIGHLAND
Regulation Number872.5410
Classification Product Code
DZC  
Date Received11/23/1993
Decision Date 05/18/1994
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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