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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Paper, Articulation
510(k) Number K870032
Device Name REVISED T-SCAN SYSTEM
Applicant
Sentek, Inc.
Third Floor
818 Connecticut Ave., NW
Washington,  DC  20006
Applicant Contact STEPHEN A WEITZMAN
Correspondent
Sentek, Inc.
Third Floor
818 Connecticut Ave., NW
Washington,  DC  20006
Correspondent Contact STEPHEN A WEITZMAN
Regulation Number872.6140
Classification Product Code
EFH  
Date Received01/05/1987
Decision Date 02/02/1987
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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