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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K911231
Device Name ORTHODONTIC WIRE
Applicant
Masel Industries, Inc.
2701 Bartram Rd.
Bristol,  PA  19007
Applicant Contact TERRY MASEL
Correspondent
Masel Industries, Inc.
2701 Bartram Rd.
Bristol,  PA  19007
Correspondent Contact TERRY MASEL
Regulation Number872.5410
Classification Product Code
EJF  
Date Received03/20/1991
Decision Date 10/08/1991
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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