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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Orthodontic
510(k) Number K936243
Device Name REGENCY TUBE
Applicant
Ortho Specialties
9525 S. 79th Ave.
Hickory Hills,  IL  60455
Applicant Contact DAVID BROSIUS
Correspondent
Ortho Specialties
9525 S. 79th Ave.
Hickory Hills,  IL  60455
Correspondent Contact DAVID BROSIUS
Regulation Number872.5410
Classification Product Code
DZD  
Date Received12/30/1993
Decision Date 02/02/1994
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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