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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 K920645
Device Name ORTHODONTIC ELASTICS BANDS
Applicant
Masel Industries, Inc.
2701 Bartram Rd.
Bristol,  PA  19007
Applicant Contact ROBERT BRIGHT
Correspondent
Masel Industries, Inc.
2701 Bartram Rd.
Bristol,  PA  19007
Correspondent Contact ROBERT BRIGHT
Regulation Number872.5410
Classification Product Code
EJF  
Date Received02/12/1992
Decision Date 07/28/1992
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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