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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positioner, Tooth, Preformed
510(k) Number K931615
Device Name NITE-GUIDE
Applicant
ORTHO-TAIN, Inc.
85th Floor Sears Tower
Chicago,  IL  60606
Applicant Contact KAY E RICKELMAN
Correspondent
ORTHO-TAIN, Inc.
85th Floor Sears Tower
Chicago,  IL  60606
Correspondent Contact KAY E RICKELMAN
Regulation Number872.5525
Classification Product Code
KMY  
Date Received04/01/1993
Decision Date 04/14/1995
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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