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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 K923372
Device Name MEMORY WIRE
Applicant
Althan, Inc.
115 Carthage Ave.
Cincinnati,  OH  45215
Applicant Contact MICHAEL E MECHLEY
Correspondent
Althan, Inc.
115 Carthage Ave.
Cincinnati,  OH  45215
Correspondent Contact MICHAEL E MECHLEY
Regulation Number872.5410
Classification Product Code
EJF  
Date Received07/09/1992
Decision Date 04/22/1994
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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