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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K902287
Device Name RASTRONICS PORTAREM 20
Applicant
Rastronics USA, Inc.
5407 W. 79th St.
P.O. Box 78130
Indianapolis,  IN  46268
Applicant Contact ROBERT P WOLF
Correspondent
Rastronics USA, Inc.
5407 W. 79th St.
P.O. Box 78130
Indianapolis,  IN  46268
Correspondent Contact ROBERT P WOLF
Regulation Number872.3060
Classification Product Code
EJT  
Date Received05/22/1990
Decision Date 08/09/1990
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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