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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mirror, Mouth
510(k) Number K935906
Device Name RANIR PLAX RX
Applicant
Ranir/Dcp Corp.
P.O. Box 8547
Grand Rapids,  MI  49518
Applicant Contact ANNE M ARMSTRONG
Correspondent
Ranir/Dcp Corp.
P.O. Box 8547
Grand Rapids,  MI  49518
Correspondent Contact ANNE M ARMSTRONG
Regulation Number872.4565
Classification Product Code
EAX  
Date Received12/10/1993
Decision Date 09/02/1994
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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