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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 K933080
Device Name ORTHOTECH DURA-GOLD BARCKETS
Applicant
Orthotech
5121 Ehrlich Rd.
Suite 102-B
Tampa,  FL  33624
Applicant Contact BRIAN LEAGHTY
Correspondent
Orthotech
5121 Ehrlich Rd.
Suite 102-B
Tampa,  FL  33624
Correspondent Contact BRIAN LEAGHTY
Regulation Number872.5410
Classification Product Code
EJF  
Date Received06/23/1993
Decision Date 03/23/1994
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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