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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K934500
Device Name METASYS AMALGAM SEPARATOR MST1
Applicant
Metasys Dental Products, Inc.
147 King St., E.
Hamilton, Ontario,  CA L8N 1B1
Applicant Contact ANDREAS LAQUA
Correspondent
Metasys Dental Products, Inc.
147 King St., E.
Hamilton, Ontario,  CA L8N 1B1
Correspondent Contact ANDREAS LAQUA
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/14/1993
Decision Date 07/13/1994
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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