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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 K902050
Device Name BIOLASTIC SUPER ELASTIC ARCHES
Applicant
Rmo, Inc.
Post Office Box 17085
Denver,  CO  80217
Applicant Contact DARRELL D PARKER
Correspondent
Rmo, Inc.
Post Office Box 17085
Denver,  CO  80217
Correspondent Contact DARRELL D PARKER
Regulation Number872.5410
Classification Product Code
EJF  
Date Received05/07/1990
Decision Date 08/03/1990
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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