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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retainer, Matrix
510(k) Number K930151
Device Name OMNI-MATRIX
Applicant
Innovative Technology , Ltd.
227 Eagle St.
Newmarket
Ontario L3y 1j8,  CA
Applicant Contact VOLKER STEIN
Correspondent
Innovative Technology , Ltd.
227 Eagle St.
Newmarket
Ontario L3y 1j8,  CA
Correspondent Contact VOLKER STEIN
Regulation Number872.4565
Classification Product Code
JEP  
Date Received01/12/1993
Decision Date 09/23/1993
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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